Multi-event March 2021 FDA Recall Belsomra by Cardinal Health Inc.

This Multi-event Class II drug recall was voluntarily initiated by Cardinal Health Inc. on March 15, 2021 for the product Belsomra. The FDA reported the reason for recall as cgmp deviations. The product was distributed in FL, GA, SC and the recall is currently terminated.

Reported Recall Events

D-0555-2021 TERMINATED D-0448-2021 TERMINATED D-0595-2021 TERMINATED D-0408-2021 TERMINATED D-0441-2021 TERMINATED D-0488-2021 TERMINATED D-0439-2021 TERMINATED D-0533-2021 TERMINATED D-0422-2021 TERMINATED D-0411-2021 TERMINATED D-0547-2021 TERMINATED D-0414-2021 TERMINATED D-0525-2021 TERMINATED D-0587-2021 TERMINATED D-0466-2021 TERMINATED D-0586-2021 TERMINATED D-0494-2021 TERMINATED D-0420-2021 TERMINATED D-0432-2021 TERMINATED D-0577-2021 TERMINATED D-0506-2021 TERMINATED D-0401-2021 TERMINATED D-0452-2021 TERMINATED D-0560-2021 TERMINATED D-0539-2021 TERMINATED D-0532-2021 TERMINATED D-0552-2021 TERMINATED D-0475-2021 TERMINATED D-0445-2021 TERMINATED D-0548-2021 TERMINATED D-0502-2021 TERMINATED D-0567-2021 TERMINATED D-0565-2021 TERMINATED D-0503-2021 TERMINATED D-0493-2021 TERMINATED D-0443-2021 TERMINATED D-0504-2021 TERMINATED D-0501-2021 TERMINATED D-0534-2021 TERMINATED D-0569-2021 TERMINATED D-0467-2021 TERMINATED D-0563-2021 TERMINATED D-0438-2021 TERMINATED D-0447-2021 TERMINATED D-0574-2021 TERMINATED D-0522-2021 TERMINATED D-0400-2021 TERMINATED D-0464-2021 TERMINATED D-0511-2021 TERMINATED D-0580-2021 TERMINATED D-0537-2021 TERMINATED D-0487-2021 TERMINATED D-0498-2021 TERMINATED D-0541-2021 TERMINATED D-0416-2021 TERMINATED D-0558-2021 TERMINATED D-0521-2021 TERMINATED D-0446-2021 TERMINATED D-0440-2021 TERMINATED D-0557-2021 TERMINATED D-0540-2021 TERMINATED D-0456-2021 TERMINATED D-0406-2021 TERMINATED D-0515-2021 TERMINATED D-0594-2021 TERMINATED D-0589-2021 TERMINATED D-0471-2021 TERMINATED D-0530-2021 TERMINATED D-0492-2021 TERMINATED D-0531-2021 TERMINATED D-0460-2021 TERMINATED D-0588-2021 TERMINATED D-0468-2021 TERMINATED D-0465-2021 TERMINATED D-0477-2021 TERMINATED D-0444-2021 TERMINATED D-0516-2021 TERMINATED D-0578-2021 TERMINATED D-0549-2021 TERMINATED D-0454-2021 TERMINATED D-0479-2021 TERMINATED D-0415-2021 TERMINATED D-0405-2021 TERMINATED D-0410-2021 TERMINATED D-0585-2021 TERMINATED D-0597-2021 TERMINATED D-0462-2021 TERMINATED D-0505-2021 TERMINATED D-0544-2021 TERMINATED D-0519-2021 TERMINATED D-0478-2021 TERMINATED D-0596-2021 TERMINATED D-0409-2021 TERMINATED D-0545-2021 TERMINATED D-0546-2021 TERMINATED D-0576-2021 TERMINATED D-0514-2021 TERMINATED D-0559-2021 TERMINATED D-0573-2021 TERMINATED D-0526-2021 TERMINATED D-0542-2021 TERMINATED D-0426-2021 TERMINATED D-0429-2021 TERMINATED D-0431-2021 TERMINATED D-0562-2021 TERMINATED D-0497-2021 TERMINATED D-0413-2021 TERMINATED D-0543-2021 TERMINATED D-0593-2021 TERMINATED D-0472-2021 TERMINATED D-0517-2021 TERMINATED D-0430-2021 TERMINATED D-0582-2021 TERMINATED D-0491-2021 TERMINATED D-0528-2021 TERMINATED D-0423-2021 TERMINATED D-0510-2021 TERMINATED D-0527-2021 TERMINATED D-0428-2021 TERMINATED D-0450-2021 TERMINATED D-0461-2021 TERMINATED D-0553-2021 TERMINATED D-0480-2021 TERMINATED D-0529-2021 TERMINATED D-0579-2021 TERMINATED D-0523-2021 TERMINATED D-0404-2021 TERMINATED D-0427-2021 TERMINATED D-0508-2021 TERMINATED D-0473-2021 TERMINATED D-0407-2021 TERMINATED D-0520-2021 TERMINATED D-0572-2021 TERMINATED D-0434-2021 TERMINATED D-0470-2021 TERMINATED D-0500-2021 TERMINATED D-0551-2021 TERMINATED D-0403-2021 TERMINATED D-0556-2021 TERMINATED D-0489-2021 TERMINATED D-0419-2021 TERMINATED D-0507-2021 TERMINATED D-0425-2021 TERMINATED D-0513-2021 TERMINATED D-0495-2021 TERMINATED D-0442-2021 TERMINATED D-0449-2021 TERMINATED D-0463-2021 TERMINATED D-0535-2021 TERMINATED D-0550-2021 TERMINATED D-0524-2021 TERMINATED D-0518-2021 TERMINATED D-0453-2021 TERMINATED D-0575-2021 TERMINATED D-0421-2021 TERMINATED D-0554-2021 TERMINATED D-0483-2021 TERMINATED D-0424-2021 TERMINATED D-0455-2021 TERMINATED D-0458-2021 TERMINATED D-0568-2021 TERMINATED D-0592-2021 TERMINATED D-0536-2021 TERMINATED D-0512-2021 TERMINATED D-0418-2021 TERMINATED D-0499-2021 TERMINATED D-0581-2021 TERMINATED D-0417-2021 TERMINATED D-0486-2021 TERMINATED D-0564-2021 TERMINATED D-0436-2021 TERMINATED D-0584-2021 TERMINATED D-0496-2021 TERMINATED D-0485-2021 TERMINATED D-0476-2021 TERMINATED D-0583-2021 TERMINATED D-0590-2021 TERMINATED D-0482-2021 TERMINATED D-0570-2021 TERMINATED D-0402-2021 TERMINATED D-0474-2021 TERMINATED D-0437-2021 TERMINATED D-0451-2021 TERMINATED D-0490-2021 TERMINATED D-0484-2021 TERMINATED D-0459-2021 TERMINATED D-0412-2021 TERMINATED D-0591-2021 TERMINATED D-0571-2021 TERMINATED D-0538-2021 TERMINATED D-0481-2021 TERMINATED D-0457-2021 TERMINATED D-0509-2021 TERMINATED D-0566-2021 TERMINATED D-0435-2021 TERMINATED D-0561-2021 TERMINATED D-0469-2021 TERMINATED D-0433-2021 TERMINATED

Recall Number: D-0555-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
848 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
Chantix (varenicline) Tablets Continuing Month Box Contains: 4 Continuing Weeks (1 mg x 56 tablets) Rx only ; Rx only Distributed by Pfizer Labs Division of Pfizer, Inc., NY, NY ,10017NDC 0069-0469-56

Batch or Lot Expiration Information

Lot# EM1069

Affected Packages Involved in this Recall

0069-0468-56 Chantix
0069-0469-56 Chantix
0069-0469-28 Chantix
0069-0471-03 Chantix
0069-0471-28 Chantix

Recall Number: D-0448-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
96 cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
Belbuca (buprenorphine hydrochloride) buccal film 300 mcg 60 pouches containing 1 buccal film each Rx only NDC 59385-023-60 Manufactured for: BioDelivery Sciences International, Inc. Raleigh, NC 27612.

Batch or Lot Expiration Information

Lot# 37674B

Affected Packages Involved in this Recall

59385-021-01 Belbuca
59385-021-60 Belbuca
59385-022-01 Belbuca
59385-022-60 Belbuca
59385-023-01 Belbuca
59385-023-60 Belbuca
59385-024-01 Belbuca
59385-024-60 Belbuca
59385-025-01 Belbuca
59385-025-60 Belbuca
59385-026-01 Belbuca
59385-026-60 Belbuca
59385-027-01 Belbuca
59385-027-60 Belbuca

Recall Number: D-0595-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
6 boxes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
CYANOCOBAL Injection 1000MCG/ML 25X1ML; NDC/UPC 69680-112-25; RX; MULTI DOSE VIAL

Batch or Lot Expiration Information

Lot# 303824

Affected Packages Involved in this Recall

69680-112-01 Cyanocobalamin
69680-112-25 Cyanocobalamin
69680-112-10 Cyanocobalamin
69680-113-10 Cyanocobalamin
69680-113-99 Cyanocobalamin
69680-121-05 Cyanocobalamin
69680-121-30 Cyanocobalamin
69680-121-10 Cyanocobalamin

Recall Number: D-0408-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
339 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
OFLOXACIN 0.3% 5ML OPTH; NDC/UPC 17478071310; RX; DROPS

Batch or Lot Expiration Information

Lot# 427297

Recall Number: D-0441-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
29 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
ESZOPICLONE 3MG 100 C4; NDC/UPC 65862096901; RX; TABLETS

Batch or Lot Expiration Information

Lot# GS0320010-A

Recall Number: D-0488-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
54 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
FaBB Vitamin B6 (as Pyridoxine Hydrochloride) 25 mg Folic Acid 2.2 mg Vitamin B12 (as Cyanocobalamin) 1.0 mg Dietary Supplement 100 Tablets Distributed by: H2-Pharma, LLC 2010 Berry Chase Place Montgomery, AL 36117

Batch or Lot Expiration Information

Lot# All Lots distributed 02/23/2021 through 03/10/2021.

Recall Number: D-0439-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
373 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
AMOXICILLIN 500MG 100; NDC/UPC 65862001401; RX; TABLETS

Batch or Lot Expiration Information

Lot# SE5019062-A

Recall Number: D-0533-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
28 tubes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
TOBREX 0.3% 3.5GM OPTH; NDC/UPC 65064435; RX; OINTMENT

Batch or Lot Expiration Information

Lot# 20B14E

Recall Number: D-0422-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
249 CARTONS

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
BUPRENORPHINE AND NALOXONE SUBLINGUAL FILM 4MG/1MG 30 POUCHES EACH CONTAINING 1 SUBLINGUAL FILM NDC/UPC 47781-0356-03; RX; FILM

Batch or Lot Expiration Information

Lot# 37890

Recall Number: D-0411-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
12 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
COSOPT (Dorzolamide Hydrochloride-Timolol Maleate Ophthalmic Solution) (Dorzolamide Hydrochloride 22.3 mg/mL Timolol Maleate 6.8 mg/mL) 10ML Ocumeter Plus Ophthalmic Dispenser Sterile Ophthlamic Solution Rx only NDC/UPC 174780-605-10 Distributed by: Akorn, Inc. Lake Forest, IL 60045

Batch or Lot Expiration Information

Lot# 430358

Recall Number: D-0547-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
2854 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
LORATADINE 10MG 100 ND 24H; NDC/UPC 345802650788; OTC; TABLETS

Batch or Lot Expiration Information

Lot# All Lots distributed 02/23/2021 through 03/10/2021.

Recall Number: D-0414-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
72 tubes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
Vaniqa (eflornithine hydrochloride) Cream, 13.9% For Topical Use Only Net wt. 1.59 oz (45 g) Rx only NDC 0023-4857-45 Manufactured for Allegan, Inc. Irvine, CA 92612

Batch or Lot Expiration Information

Lot# 113780

Recall Number: D-0525-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
122 inhalers

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
ASMANEX TWST 220MCG 60INH PWD; NDC/UPC 85134102; RX; INHALER MEDICAL INTERNAL - MAY OR MAY NOT BE AEROSOL

Batch or Lot Expiration Information

Lot# T023471

Recall Number: D-0587-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
31 cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
Restora Omega-3 enhanced Lactobacillus Casei KE-99 30 Capsules 1 A Day Nutritional Supplement NDC 52747-200-30 Marketed by US Pharmaceutical Corporation, P.O. Box 360465, Decatur, GA 30036

Batch or Lot Expiration Information

Lot# All Lots distributed 02/23/2021 through 03/10/2021.

Recall Number: D-0466-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
13 packets

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
Prilosec (Omeprazole Magnesium) For Delayed-Release Oral Suspension 10 mg Rx only NDC 70515-610-01 Mfd. for: Covis Pharma, Zug, 6300 Switzerland

Batch or Lot Expiration Information

Lot# CACU

Affected Packages Involved in this Recall

70515-625-01 Prilosec
70515-610-01 Prilosec

Recall Number: D-0586-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
86 BOTTLE

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
TRAMADOL HYDROCHLORIDE TABLETS USP 100MG, 100-count bottle, Rx Only, Manufactured by: Rubicon Research :Private Limited, Ambernath, Dist. Thane, 421506 India, NDC: 52817-0196-10

Batch or Lot Expiration Information

Lot# 200340H1

Recall Number: D-0494-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
35 bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
Levofloxacin Injection in 5% Dextrose 500 mg in 100 mL 5% Dextrose (5 mg/mL) 24x100 mL Single Dose Flexible Containers NDC 0143-9721-24 West-Ward Pharmaceutical Corp Eatontown, NJ 07724 USA

Batch or Lot Expiration Information

Lot# 2007046.1

Affected Packages Involved in this Recall

0143-9722-01 Levofloxacin
0143-9722-24 Levofloxacin
0143-9721-01 Levofloxacin
0143-9721-24 Levofloxacin
0143-9720-01 Levofloxacin
0143-9720-24 Levofloxacin

Recall Number: D-0420-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
759 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
Vraylar (cariprazine) capsules in all pack sizes, styles and strengths Rx only Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054

Batch or Lot Expiration Information

Lot# W04494

Recall Number: D-0432-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
3 CARTON

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
GEMCITABINE INJECTION 200MG/5.26ML; NDC/UPC 72485-221-02; RX; SINGLEDOSE VIAL

Batch or Lot Expiration Information

Lot# 7T10050A

Affected Packages Involved in this Recall

72485-221-02 Gemcitabine

Recall Number: D-0577-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
414 boxes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
EPINEPHRINE INJECTION USP, 0.3MG (AUTO-INJECTORS) FOR ALLERGIC EMERGENCIES (ANAPHYLAXIS) 2 Auto-Injectors and 1 Trainer, Manufactured for: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454 NDC 0093-5986-27

Batch or Lot Expiration Information

Lot# 033J20AA

Affected Packages Involved in this Recall

0093-5986-19 Epinephrine
0093-5986-27 Epinephrine
0093-5985-19 Epinephrine
0093-5985-27 Epinephrine

Recall Number: D-0506-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
4 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
Pantoprazole Sodium Delayed-Release Tablets, USP 20 mg* 90 Tablets Rx Only NDC 62175-180-46 Distributed by: Kremers Urban Pharmaceuticals Inc. Princeton, NJ 08540, USA

Batch or Lot Expiration Information

Lot# 20249489A

Affected Packages Involved in this Recall

62175-617-46 Pantoprazole Sodium
62175-617-43 Pantoprazole Sodium
62175-180-46 Pantoprazole Sodium
62175-180-43 Pantoprazole Sodium
62175-618-46 Pantoprazole Sodium
62175-618-43 Pantoprazole Sodium

Recall Number: D-0401-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
4 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
NIACIN 250MG 110; NDC/UPC 740985228494; OTC; TABLETS

Batch or Lot Expiration Information

Lot# All Lots distributed 02/23/2021 through 03/10/2021.

Recall Number: D-0452-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
17 patches

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
CATAPRES-TTS-2 1X4; NDC/UPC 597003234; RX; ADHESIVE PATCHES

Batch or Lot Expiration Information

Lot# 1905666/2

Recall Number: D-0560-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
205 cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
Intrarosa Prasterone Vaginal Inserts 6.5 mg 28 inserts/applicators Rx Only Manufactured for: Ednoceutics, Inc. Quebec City, Canada, G1V 4M7 Distributed by: AMAG Pharmaceuticals, Inc. Waltam, MA 02451, NDC 64011-601-28

Batch or Lot Expiration Information

Lot# R81339

Recall Number: D-0539-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
55 Boxes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
ZOLPIDEM TARTRATE SUBLINGUAL TABLET 3.5 MG 30 UNIT DOSE POUCHES; NDC/UPC 49884089911; RX; EACH POUCH CONTAINS ONE SUBLINGUAL TABLET

Batch or Lot Expiration Information

Lot# 12699501

Recall Number: D-0532-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
205 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
Vitamin D3 Cholecalciferol 50,000 IU Dietary Supplement 12 Capsules NDC 75834-020-12 Marketed by: Nivagen Pharmaceuticals, Inc. Sacramento, CA 95827 USA

Batch or Lot Expiration Information

Lot# All Lots distributed 02/23/2021 through 03/10/2021.

Recall Number: D-0552-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
49 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
LYRICA (pregabalin) capsules, 200mg 90-count bottle, Rx Only, Distributed by: Parke-Davis, Division of Pfizer Inc., NY, NY 10017, MADE IN SINGAPORE

Batch or Lot Expiration Information

Lot# CK1081

Recall Number: D-0475-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
41 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
Prenatal Tablets Gluten Free Multivitamin/ Multimineral Dietary Supplement for Pregnant and Lactating Women UD 100 Tablets (10x10) NDC 77333-715-10 GenDose Pharmaceuticals

Batch or Lot Expiration Information

Lot# All Lots distributed 02/23/2021 through 03/10/2021.

Recall Number: D-0445-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
64 droptainers

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
MURO-128 2% 15ML OPTH; NDC/UPC 324208276150; OTC; DROPS

Batch or Lot Expiration Information

Lot# All Lots distributed 02/23/2021 through 03/10/2021.

Recall Number: D-0548-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
1371 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
Cetirizine Hydrochloride Tablets, 10 mg, 300 Count; NDC/UPC 345802919878; OTC; TABLETS

Batch or Lot Expiration Information

Lot# All Lots distributed 02/23/2021 through 03/10/2021.

Recall Number: D-0502-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
237 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
PHENTERMINE HCL 37.5MG 100 C4; NDC/UPC 10702002901; RX; CAPSULES

Batch or Lot Expiration Information

Lot# 16649A

Recall Number: D-0567-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
1391 tubes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
Collagenase Santyl Ointment 250 units/g 30 grams Rx Only Marketed by Smith & Nephew, Inc., Fort Worth, TX 76107, NDC 50484-010-30

Batch or Lot Expiration Information

Lot# 191960

Affected Packages Involved in this Recall

50484-010-30 Collagenase Santyl
50484-010-90 Collagenase Santyl

Recall Number: D-0565-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
143 tubes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
HYDROCORTISONE 1% 30gm cream

Batch or Lot Expiration Information

Lot# KK4912

Recall Number: D-0503-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
422 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
Infants Aqueous Vitamin D Oral Drops 400 IU/mL 50 mL (1 2/3 fl oz) Manufactrued by: Silarx Pharmaceuticals, Inc. 19 West Street Spring Valley, NY 10977 USA

Batch or Lot Expiration Information

Lot# All Lots distributed 02/23/2021 through 03/10/2021.

Recall Number: D-0493-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
12 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
LEUCOVORIN 15MG 24; NDC/UPC 54449810; RX; TABLETS

Batch or Lot Expiration Information

Lot# 064159A

Recall Number: D-0443-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
463 boxes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
LOTEMAX SM (loteprednol etabonate ophthalmic gel) 0.38% 5GM; NDC/UPC 24208-0507-07; RX; GEL

Batch or Lot Expiration Information

Lot# 352162

Recall Number: D-0504-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
357 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
Ferrous Sulfate 75 mg (equivalent to 15 mg Iron) Per 1.0 mL Alcohol 0.2% v/v Drops Iron Supplement Drops For Infants and Toddlers 50 mL (1 2/3 fl oz) NDC 54838-011-50 Manufactured by: Silarx Pharmaceuticals, Inc. 19 West Street Spring Valley, NY 10977 USA

Batch or Lot Expiration Information

Lot# All Lots distributed 02/23/2021 through 03/10/2021.

Recall Number: D-0501-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
16 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
PHENTERMINE HCL 30MG 100 C4; NDC/UPC 10702002801; RX; CAPSULES

Batch or Lot Expiration Information

Lot# 16667A

Recall Number: D-0534-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
348 droptainers

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
Ilevro (nepafenac ophthalmic suspension) 0.3% 3 mL Sterile Rx Only NDC 0065-1750-14 Alcon Laboratories, Inc. 6201 South Freeway Fort Worth, Texas 76134

Batch or Lot Expiration Information

Lot# 10CPE

Recall Number: D-0569-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
133 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
COREG CR (carvedilol phosphate) Extended Release Capsules, 80 mg, 30-count bottle, Rx Only,/UPC 57664066683

Batch or Lot Expiration Information

Lot# P0978

Recall Number: D-0467-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
1 bottle

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
Iron 100 with Vitamin C Tablets Dietary Supplement 100 Tablets NDC 60258-099-01 Distributed By: Cypress Pharmaceutical, Inc. 135 Industrial Blvd. Madison, MS 39110

Batch or Lot Expiration Information

Lot# All Lots distributed 02/23/2021 through 03/10/2021.

Recall Number: D-0563-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
148 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
medroxyprogesterone acetate injectable suspension, USP, 150MG/ML 1ML, Rx Only, Distributed by: Greenstone LLC, Peapack, NJ 07977, NDC 59762-4538-02

Batch or Lot Expiration Information

Lot# DN0428

Recall Number: D-0438-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
20 CARTONS

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
Eletriptan Hydrobromide Tablets 20 mg* 6(1x6) Unit-dose Tablets Rx only NDC 59651-104-69 Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Highstown Road East Windsor, NJ 08520

Batch or Lot Expiration Information

Lot# EA2020001-A

Affected Packages Involved in this Recall

59651-104-06 Eletriptan Hydrobromide
59651-104-69 Eletriptan Hydrobromide
59651-105-06 Eletriptan Hydrobromide
59651-105-69 Eletriptan Hydrobromide
59651-105-93 Eletriptan Hydrobromide

Recall Number: D-0447-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
318 droptainers

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
DEXAMETH SOD PHOS 0.1% 5ML; NDC/UPC 24208072002; RX; DROPS

Batch or Lot Expiration Information

Lot# 353351

Recall Number: D-0574-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
41 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
NEOMYCIN SULF TABLETS, USP, 500mg, 100-count bottle, Rx Only, Distributed by: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC: 0093-1177-01

Batch or Lot Expiration Information

Lot# 3006910

Affected Packages Involved in this Recall

0093-1177-01 Neomycin Sulfate

Recall Number: D-0522-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
119 cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
Belsomra (suvorexant) tablets 10 mg Each tablet contains 10 mg suvorexant. This package contains 30 Tablets in 3 Blister Cards. Each Blister Card contains 10 Tablets Rx only NDC 00006-0033-30 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. Whitehouse Station, NJ 08889, USA

Batch or Lot Expiration Information

Lot# 1791139

Recall Number: D-0400-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
55 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
THERAPEUTIC M 130; NDC/UPC 740985223680; OTC; TABLETS

Batch or Lot Expiration Information

Lot# All Lots distributed 02/23/2021 through 03/10/2021.

Recall Number: D-0464-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
40 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
Nadolol Tablets, USP 40 mg 100 Tablets Rx Only NDC 69097-868-07 Manufactured for: Cipla USA Inc. 9100 S. Dadeland Blvd., Suite 1599 Miami, FL 33156

Batch or Lot Expiration Information

Lot# NB100156

Affected Packages Involved in this Recall

69097-867-07 Nadolol
69097-867-15 Nadolol
69097-867-02 Nadolol
69097-868-02 Nadolol
69097-868-07 Nadolol
69097-868-15 Nadolol
69097-869-02 Nadolol
69097-869-07 Nadolol
69097-869-15 Nadolol

Recall Number: D-0511-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
71 tubes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
MICONAZOLE 7 2% 45GM APL; NDC/UPC 009047734459; OTC; CREAM

Batch or Lot Expiration Information

Lot# All Lots distributed 02/23/2021 through 03/10/2021.

Recall Number: D-0580-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
828 inhalers

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
Levalbuterol tartrate HFA Inhalation Aerosol 45 mcg/actuation 200 Metered Inhalations Net Contents: 15 g Rx Only NDC 0591-2927-54 Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA

Batch or Lot Expiration Information

Lot# 200093

Affected Packages Involved in this Recall

0591-2927-54 Levalbuterol Tartrate Hfa Inhalation

Recall Number: D-0537-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
60 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
Benztropine Mesylate Tablets, USP in all pack sizes, styles and strengths Manufactured for: Qualitest Pharmaceuticals Huntsville, AL 35811

Batch or Lot Expiration Information

Lot# S2008031

Recall Number: D-0487-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
23 tubes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
Hydrocortisone Ointment USP 1% Maximum Strength Net Wt. 1 oz (28 g) NDC 0472-0345-56 Manufactured by: Actavis Mid Atlantic LLC 1877 Kawai Road, Lincolnton, NC 28902

Batch or Lot Expiration Information

Lot# All Lots distributed 02/23/2021 through 03/10/2021

Recall Number: D-0498-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
534 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
INVEGA SUSTENNA 156MG/1ML; NDC/UPC 50458056301; RX; SYRINGES

Batch or Lot Expiration Information

Lot# KIB0M00

Recall Number: D-0541-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
39 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
RISPERIDONE 1MG/ML 30ML; NDC/UPC 50458059601; RX; SOLUTION (USUALLY NOT OTIC, OPTH, NASAL DROPS)

Batch or Lot Expiration Information

Lot# KHB2701

Recall Number: D-0416-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
3688 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
RESTASIS 0.05%30X 0.4ML OPTH PF; NDC/UPC 23916330; RX; DROPS/Restasis 0.05% 60x0.4 mL OPTH PF; NDC/UPC 23916330; RX

Batch or Lot Expiration Information

Lot# T1202

Recall Number: D-0558-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
49 CARTON

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
PROMETHAZINE PLAIN ORAL SOLUTION 6.25MG/5ML 473ML; ; RX; SOLUTION (USUALLY NOT OTIC, OPTH, NASAL DROPS), Rx Only, NDC 0211-0927-16

Batch or Lot Expiration Information

Lot# 20001481

Recall Number: D-0521-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
147

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
PEDIA-LAX 66ML; NDC/UPC 301320202205; OTC; ENEMA

Batch or Lot Expiration Information

Lot# All Lots distributed 02/23/2021 through 03/10/2021.

Recall Number: D-0446-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
47 droptainers

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
TOBRAMY/DEX 0.3-0.1% 10ML OPTH; NDC/UPC 24208029510; RX; DROPS

Batch or Lot Expiration Information

Lot# 350861

Recall Number: D-0440-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
1935 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
ONDANSETRON HCL 4MG 30; NDC/UPC 65862018730; RX; TABLETS

Batch or Lot Expiration Information

Lot# ON0420015-A

Recall Number: D-0557-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
13 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
LEVOXYL Tablets, USD, 150MCG, 100-count bottle, Rx Only, Distributed by Pfizer Inc., New York, NY 10017, MADE IN AUSTRIA, NDC: 60793-858-01

Batch or Lot Expiration Information

Lot# 20D27

Affected Packages Involved in this Recall

60793-850-10 Levoxyl
60793-850-01 Levoxyl
60793-851-10 Levoxyl
60793-851-01 Levoxyl
60793-852-10 Levoxyl
60793-852-01 Levoxyl
60793-853-10 Levoxyl
60793-853-01 Levoxyl
60793-854-10 Levoxyl
60793-854-01 Levoxyl
60793-855-10 Levoxyl
60793-855-01 Levoxyl
60793-856-10 Levoxyl
60793-856-01 Levoxyl
60793-857-10 Levoxyl
60793-857-01 Levoxyl
60793-858-10 Levoxyl
60793-858-01 Levoxyl
60793-859-10 Levoxyl
60793-859-01 Levoxyl
60793-860-10 Levoxyl
60793-860-01 Levoxyl

Recall Number: D-0540-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
236 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
HySept Solution 0.25% Sodium Hypochlorite Solution 473 mL (16 fl. oz.) NDC 39328-063-25 Manufactured in USA Patrin Pharma, Skokie, IL 60076

Batch or Lot Expiration Information

Lot# All Lots distributed 02/23/2021 through 03/10/2021.

Recall Number: D-0456-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
284 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
Synjardy (empagliflozin and metformin hydrochloride) Tablets 12.5 mg/1000 mg 60 tablets Rx only NDC 0597-0168-69 Distributed by: Boehringer Ingleheim (BI) Pharmaceuticals, Inc. Ridgefield, CT 06877 USA

Batch or Lot Expiration Information

Lot# C80102

Recall Number: D-0406-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
51 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
METHOCARBAMOL 500MG 500; NDC/UPC 71093014005; RX; TABLETS

Batch or Lot Expiration Information

Lot# UMETA0036A

Recall Number: D-0515-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
53 BOTTLE

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
VITAMIN D3 25MCG 90 TABLETS; NDC/UPC 880681168004; OTC; TABLETS

Batch or Lot Expiration Information

Lot# All Lots distributed 02/23/2021 through 03/10/2021.

Recall Number: D-0594-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
2 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
Corgard (nadolol tablets, USP) 40 mg 100 Tablets Rx only NDC 27505-101-01 Distributed by US WorldMeds, LLC, Louisville, KY 40241

Batch or Lot Expiration Information

Lot# 19T28

Recall Number: D-0589-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
796 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
VIMPAT(lacosamide) Tablets ,100 mg, 60-count bottle; Rx Only, Manufactured for: UCB, Inc. Smyrna, GA 30080

Batch or Lot Expiration Information

Lot# 912056

Recall Number: D-0471-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
504 cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
Ivermectin Tablets USP 3 mg 20 Tablets (2 Foil Strips of 10 tablets each) Rx Only NDC 4799-806-01 Manufactured for: Edenbridge Pharmaceuticals, LLC Parsippany, NJ 07054 877-381-3336

Batch or Lot Expiration Information

Lot# A1003273A

Recall Number: D-0530-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
47 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
NAT B VIT D3 2000U 100; NDC/UPC 079854041125; OTC; TABLETS

Batch or Lot Expiration Information

Lot# All Lots distributed 02/23/2021 through 03/10/2021.

Recall Number: D-0492-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
298 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
LITHIUM CARB 150MG 100; NDC/UPC 54252625; RX; CAPSULES

Batch or Lot Expiration Information

Lot# AB1024A

Recall Number: D-0531-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
523 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
Vitamin D3 Cholecalciferol 50,000 IU Dietary Supplement 100 Capsules NDC 75834-020-01 Marketed by: Nivagen Pharmaceuticals, Inc. Sacramento, CA 95827

Batch or Lot Expiration Information

Lot# All Lots distributed 02/23/2021 through 03/10/2021.

Recall Number: D-0460-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
3 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
PRAVACHOL 40MG 90; NDC/UPC 3519410; RX; TABLETS

Batch or Lot Expiration Information

Lot# ABA4203A1

Recall Number: D-0588-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
32 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
INTEGRA 325/40/3mg 90-count bottle, NDC: 52747-710-60

Batch or Lot Expiration Information

Lot# All Lots distributed 02/23/2021 through 03/10/2021.

Recall Number: D-0468-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
75 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
BENICAR 40MG 30; NDC/UPC 65597010430; RX; TABLETS

Batch or Lot Expiration Information

Lot# 1703296

Recall Number: D-0465-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
40 bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
CIPROFLOX/D5W 400/200 24X200ML; NDC/UPC 36000000924; RX; IV SOLUTION (PIGGYBACK)

Batch or Lot Expiration Information

Lot# A0D0924A

Recall Number: D-0477-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
237 inhalers

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
FLOVENT DISKUS 100MCG 60; NDC/UPC 173060202; RX; INHALER MEDICAL INTERNAL - MAY OR MAY NOT BE AEROSOL

Batch or Lot Expiration Information

Lot# 9E9A

Recall Number: D-0444-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
2 carton

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
BENZEFOAM EMOLLIENT FOAM BENZOYL PEROXIDE 5.3% 100GM TOP EMOL NDC 187-0194--10; OTC; FOAMS

Batch or Lot Expiration Information

Lot# All Lots distributed 02/23/2021 through 03/10/2021.

Recall Number: D-0516-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
19 BOTTLE

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
VITAMIN D3 25MCG 180 TABLETS; NDC/UPC 880681168011; OTC; TABLETS

Batch or Lot Expiration Information

Lot# All Lots distributed 02/23/2021 through 03/10/2021.

Recall Number: D-0578-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
1776 boxes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
EPINEPHRINE INJECTION USP, 0.15 MG (AUTO-INJECTORS) FOR ALLERGIC EMERGENCIES (ANAPHYLAXIS) 2 Auto-Injectors and 1 Trainer, Manufactured for: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454 NDC 0093-5985-27

Batch or Lot Expiration Information

Lot# 025C20AA

Affected Packages Involved in this Recall

0093-5986-19 Epinephrine
0093-5986-27 Epinephrine
0093-5985-19 Epinephrine
0093-5985-27 Epinephrine

Recall Number: D-0549-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
180 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
Podofilox Topical Solution 0.5% 3.5ML, Rx Only, For Topical Use Only, Manufactured by Perrigo, Minneapolis, MN 55427, NDC 0574-0611-05.

Batch or Lot Expiration Information

Lot# 402995

Affected Packages Involved in this Recall

0574-0611-05 Podofilox

Recall Number: D-0454-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
667 inhalers

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
ATROVENT HFA 17MCG 12.9GM; NDC/UPC 597008717; RX; INHALER MEDICAL INTERNAL - MAY OR MAY NOT BE AEROSOL

Batch or Lot Expiration Information

Lot# 200155

Recall Number: D-0479-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
513 inhalers

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
ARNUITY ELLIPTA 100MCG 30INH; NDC/UPC 173087410; RX; INHALER MEDICAL INTERNAL - MAY OR MAY NOT BE AEROSOL

Batch or Lot Expiration Information

Lot# F79E

Recall Number: D-0415-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
964 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
UBRELVY 100MG 10UD CPLT; NDC/UPC 23650110; RX; TABLETS

Batch or Lot Expiration Information

Lot# 1658641

Recall Number: D-0405-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
123 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
Synthroid (levothyroxine sodium tablets, USP) in all pack sizes, styles and concentrations Rx only Abbott Laboratories North Chicago, IL

Batch or Lot Expiration Information

Lot# 1138959

Recall Number: D-0410-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
424 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
Atropine Sulfate Ophthalmic Solution, USP 1% For Topical Application To The Eye Sterile 5 mL Rx only NDC 17478-215-05 Manufactured by: Akorn, Inc.

Batch or Lot Expiration Information

Lot# 071520A

Recall Number: D-0585-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
80 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
Folivane-Plus with Ascorbic Acid Precursors Iron/Folic Acid/Vitamin Supplement Capsules 90 Capsules Rx Only NDC 13811-539-90 Manufactured for: Trigen Laboratories, Inc., Sayreville, NJ 08872

Batch or Lot Expiration Information

Lot# All Lots distributed 02/23/2021 through 03/10/2021.

Recall Number: D-0597-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
10 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
Enalapril Maleate Tablets, USP 2.5 mg 100 tablets Rx only Distributed by: Cardinal Health, NDC 64679-923-02

Batch or Lot Expiration Information

Lot# DV10467

Recall Number: D-0462-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
16 tubes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
Sodium Sulfacetamide 9.8% & Sulfur 4.8% Cleanser (sodium sulfacetamide 9.8% and sulfur 4.8%) Net Wt. 10 oz. (285 g) Rx Only NDC 50096-502-10 Manufactured for: Rosemar Labs, LLC 2100 West Loop South Suite 900 Houston, TX 77027

Batch or Lot Expiration Information

Lot# 59314

Recall Number: D-0505-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
78 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
SILADRYL 12.5/5ML 118ML SF AF; NDC/UPC 354838135404; OTC; LIQUID

Batch or Lot Expiration Information

Lot# All Lots distributed 02/23/2021 through 03/10/2021.

Recall Number: D-0544-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
163 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
Polyethylene Glycol 3350 Powder for Solution, Laxative Net Wt 4.1 oz (119 g) 7 Once-Daily Doses NDC 45802-868-01 Distributed by Perrigo Allegan, MI 49010

Batch or Lot Expiration Information

Lot# All Lots distributed 02/23/2021 through 03/10/2021.

Affected Packages Involved in this Recall

45802-868-01 Polyethylene Glycol 3350
45802-868-03 Polyethylene Glycol 3350
45802-868-02 Polyethylene Glycol 3350
45802-868-66 Polyethylene Glycol 3350

Recall Number: D-0519-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
427 BOTTLE

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
VITAMIN D3 50MCG 100 CALC; NDC/UPC 880681170007; OTC; TABLETS

Batch or Lot Expiration Information

Lot# All Lots distributed 02/23/2021 through 03/10/2021.

Recall Number: D-0478-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
297 inhalers

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
ADVAIR HFA 45-21MCG 12GM; NDC/UPC 173071520; RX; INHALER MEDICAL INTERNAL - MAY OR MAY NOT BE AEROSOL

Batch or Lot Expiration Information

Lot# TH4K

Recall Number: D-0596-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
15 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide Oral Syrup Net: 1 Pint (473 mL) Bulk Container-Not for Household Use Rx Only NDC 60432-275-16 Distributed By: Wockhardt USA, LLC Parsippany, NJ 07054

Batch or Lot Expiration Information

Lot# UV1092

Recall Number: D-0409-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
240 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
LIDOCAINE HCL VISC 2% 100ML; NDC/UPC 50383077504; RX; SOLUTION (USUALLY NOT OTIC, OPTH, NASAL DROPS)

Batch or Lot Expiration Information

Lot# 373577

Recall Number: D-0545-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
934 boxes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
POLYETHYLENE GLYCOL 3350 Powder for Solution Osmotic Laxative 14 once-daily doses 14 Packet- Newt Wt. 0.5 oz (17g) each NDC 45802-868-66

Batch or Lot Expiration Information

Lot# All Lots distributed 02/23/2021 through 03/10/2021.

Affected Packages Involved in this Recall

45802-868-01 Polyethylene Glycol 3350
45802-868-03 Polyethylene Glycol 3350
45802-868-02 Polyethylene Glycol 3350
45802-868-66 Polyethylene Glycol 3350

Recall Number: D-0546-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
321 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
Fexofenadine Hydrochloride Tablets, 180 mg Antihistamine Non-Drowsy 100 Tablets 180 mg Each NDC 45802-571-78 Distributed By Perrigo Allegan, MI 49010

Batch or Lot Expiration Information

Lot# All Lots distributed 02/23/2021 through 03/10/2021.

Recall Number: D-0576-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
91 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
PENICILLIN V POT for Oral Solution, USP 125mg/5mL 100mL (when mixed) Rx Only, Manufactured for: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0093-4125-73

Batch or Lot Expiration Information

Lot# 35446365A

Affected Packages Involved in this Recall

0093-1172-01 Penicillin V Potassium
0093-1172-10 Penicillin V Potassium
0093-1174-01 Penicillin V Potassium
0093-1174-10 Penicillin V Potassium
0093-4125-73 Penicillin V Potassium
0093-4125-74 Penicillin V Potassium
0093-4127-73 Penicillin V Potassium
0093-4127-74 Penicillin V Potassium

Recall Number: D-0514-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
380 BOTTLE

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
VITAMIN D3 50MCG 100 SOFTGELS; NDC/UPC 880681009000; OTC; GELCAP

Batch or Lot Expiration Information

Lot# All Lots distributed 02/23/2021 through 03/10/2021.

Recall Number: D-0559-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
8 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
Nature's Truth Absorbable Calcium 1200 mg plus D3 5000 IU 120 Softgels Dietary Supplements Carefully Designed and Distributed by Nature's Truth LLC. Ronkonkoma, NY 11779, UPC 840093100672

Batch or Lot Expiration Information

Lot# All Lots distributed 02/23/2021 through 03/10/2021.

Recall Number: D-0573-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
26895 inhalers

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
Proair HFA (albuterol sulfate) Inhalation Aerosol 90 mcg per actuation With Dose Counter 200 Metered Inhalation 8,5 g Net Contents Rx only NDC 59310-579-22 Mktd by: Teva Respiratory, LLC Horsham, PA 19044 Mfd by: IVAX Pharmaceuticals Ireland Waterford, Ireland

Batch or Lot Expiration Information

Lot# DAF02A

Recall Number: D-0526-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
112 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
Levothyroxine Sodium Tablets, USP 125 mcg (0.125 mg) 90 Tablets Rx only NDC 0378-1813-77 Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.

Batch or Lot Expiration Information

Lot# 3109046

Affected Packages Involved in this Recall

0378-1800-77 Levothyroxine Sodium
0378-1800-10 Levothyroxine Sodium
0378-1803-77 Levothyroxine Sodium
0378-1803-10 Levothyroxine Sodium
0378-1805-77 Levothyroxine Sodium
0378-1805-10 Levothyroxine Sodium
0378-1807-77 Levothyroxine Sodium
0378-1807-10 Levothyroxine Sodium
0378-1809-77 Levothyroxine Sodium
0378-1809-10 Levothyroxine Sodium
0378-1811-77 Levothyroxine Sodium
0378-1811-10 Levothyroxine Sodium
0378-1813-77 Levothyroxine Sodium
0378-1813-10 Levothyroxine Sodium
0378-1823-77 Levothyroxine Sodium
0378-1823-10 Levothyroxine Sodium
0378-1815-77 Levothyroxine Sodium
0378-1815-10 Levothyroxine Sodium
0378-1817-77 Levothyroxine Sodium
0378-1817-10 Levothyroxine Sodium
0378-1819-77 Levothyroxine Sodium
0378-1819-10 Levothyroxine Sodium
0378-1821-77 Levothyroxine Sodium

Recall Number: D-0542-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
5 tubes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
Benzoyl Peroxide 2.5% Aqueous Base, Acne Treatment Gel Net Wt. 2.1 oz (60 g) NDC 45802-101-96 Distributed By Perrigo Allegan, MI 49010

Batch or Lot Expiration Information

Lot# All Lots distributed 02/23/2021 through 03/10/2021.

Affected Packages Involved in this Recall

45802-101-96 Benzoyl Peroxide

Recall Number: D-0426-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
64 BOXES

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
ENOXAPARIN DOFIUM INJRVYION, UPD 150MG/1ML 10X1ML SINGLE DOSE SYRINGES; NDC/UPC 60505-0798-4; RX; SYRINGES

Batch or Lot Expiration Information

Lot# CV006

Recall Number: D-0429-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
328 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
Edarbi (azilsartan medoxomil) tablets 80 mg 30 Tablets Rx Only NDC 60631-080-30 Manufactured for: arbor Pharmaceuticals Atlanta, GA 30328

Batch or Lot Expiration Information

Lot# 78902-1

Affected Packages Involved in this Recall

60631-040-07 Edarbi
60631-040-30 Edarbi
60631-040-77 Edarbi
60631-080-07 Edarbi
60631-080-30 Edarbi
60631-080-77 Edarbi

Recall Number: D-0431-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
273 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
edarbyclor Azilsartan Medoxomil and Chlorthalidone Tablets 40 mg*/25 mg *Each tablet contains: 42.68 mg azilsartan kamedoxomil (equivalent to 40 mg azilsartan medoxomil) and 25 mg chlorthalidone. 30 Tablets Rx Only NDC 60631-425-30 Manufactured for Arbor Pharmaceuticals Atlanta, GA 30328

Batch or Lot Expiration Information

Lot# 79551

Affected Packages Involved in this Recall

60631-412-30 Edarbyclor
60631-425-30 Edarbyclor

Recall Number: D-0562-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
286 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
Medroxyprogesterone acetate injectable suspension, USP 150 mg per mL 1 mL Prefilled Syringe Rx only NDC 59762-4538-2 Distributed by: Greenstone, LLC. Peapack, NJ 07977

Batch or Lot Expiration Information

Lot# EC4744

Recall Number: D-0497-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
37 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
Tylenol Acetaminophen Pain Regular Strength Liquid Gels Pain Reliever Fever Reducer 20 Liquid Gels 325 mg each NDC 50580-487-20

Batch or Lot Expiration Information

Lot# All Lots distributed 02/23/2021 through 03/10/2021.

Recall Number: D-0413-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
152 CARTON

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
BROMFENAC OPHTHALMIC SOLUTION 0.09% 1.7ML NDC/UPC 62332-508-17; RX; DROPS

Batch or Lot Expiration Information

Lot# AGV009

Affected Packages Involved in this Recall

62332-508-17 Bromfenac Ophthalmic Solution 0.09%

Recall Number: D-0543-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
31 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
Benzoyl Peroxide 10% Acne Medication Wash Net Wt 5 oz (142 g) Distributed By Perrigo Allegan, MI 49010, NDC 45802-318-01

Batch or Lot Expiration Information

Lot# All Lots distributed 02/23/2021 through 03/10/2021.

Affected Packages Involved in this Recall

45802-318-01 Benzoyl Peroxide
45802-318-34 Benzoyl Peroxide

Recall Number: D-0593-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
35 BOTTLE

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
HALOPERIDOL TABLETS 20mg, USP, 100-count bottle, Rx Only Distributed by: Usher-Smith Laboratories, LLC, Maple Grove, MN 55369, NDC: 0832-1560-11

Batch or Lot Expiration Information

Lot# 2007346C

Affected Packages Involved in this Recall

0832-1510-11 Haloperidol
0832-1520-11 Haloperidol
0832-1520-89 Haloperidol
0832-1520-01 Haloperidol
0832-1530-11 Haloperidol
0832-1540-11 Haloperidol
0832-1540-89 Haloperidol
0832-1540-01 Haloperidol
0832-1550-11 Haloperidol
0832-1550-89 Haloperidol
0832-1550-01 Haloperidol
0832-1560-11 Haloperidol

Recall Number: D-0472-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
30 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
Banzel (rufinamide) tablets 200 mg 120 tablets Rx only NDC 62856-582-52 Manufactured by Eisai Co., Ltd. Marketed by Eisai Inc. Woodcliff Lake, NJ 07677

Batch or Lot Expiration Information

Lot# 80643

Affected Packages Involved in this Recall

62856-582-52 Banzel
62856-582-04 Banzel
62856-583-14 Banzel
62856-583-52 Banzel
62856-584-46 Banzel

Recall Number: D-0517-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
701 CARTON

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
DIBUCAINE TOPICAL ANESTHETIC 1% HEMORRHOIDAL OINTMENT 28GM ; NDC/UPC 0536-1211-95; OTC; OINTMENT

Batch or Lot Expiration Information

Lot# All Lots distributed 02/23/2021 through 03/10/2021.

Affected Packages Involved in this Recall

0536-1211-95 Dibucaine Topical Anesthetic 1% Hemorrhoidal

Recall Number: D-0430-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
244 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
edarbyclor Azilsartan Medoxomil and Chlorthalidone Tablets 40 mg*/12.5 mg 30 Tablets Rx Only NDC 60631-412-30 Manufactured for: arbor Pharmaceuticals, LLC. Atlanta, GA 30328

Batch or Lot Expiration Information

Lot# 78520

Affected Packages Involved in this Recall

60631-412-30 Edarbyclor
60631-425-30 Edarbyclor

Recall Number: D-0582-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
92 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
Sulindac Tablets, USP, 200mg 100-count bottles, Rx Only, Manufactured by: Epic Pharma, LLC, Laurelton, NY 11413, NDC 42806-011-01

Batch or Lot Expiration Information

Lot# 1578F201

Affected Packages Involved in this Recall

42806-018-01 Sulindac
42806-018-05 Sulindac
42806-018-10 Sulindac
42806-011-01 Sulindac
42806-011-05 Sulindac
42806-011-10 Sulindac

Recall Number: D-0491-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
35 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
Calcium Acetate Capsules 667 mg 200 Capsules Rx only NDC 23155-531-02 Manufactured for: Heritage Pharmaceuticals Inc. Eatontown, NJ 07724

Batch or Lot Expiration Information

Lot# L200801

Affected Packages Involved in this Recall

23155-531-02 Calcium Acetate
23155-531-10 Calcium Acetate
23155-531-18 Calcium Acetate

Recall Number: D-0528-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
620 injector

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
Epinephrine Injection, USP Auto-Injectors in all strengths, packs and styles Manufactured for Mylan Specialty L.P., Morgantown, WV , NDC: 9502-500-01, 49502-500-02, 49502-500-92, 49502-501-01

Batch or Lot Expiration Information

Lot# 0FM544

Affected Packages Involved in this Recall

49502-500-01 Epipen
49502-500-02 Epipen
49502-500-92 Epipen
49502-501-01 Epipen Jr
49502-501-02 Epipen Jr
49502-501-92 Epipen Jr

Recall Number: D-0423-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
15885 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
Oseltamivir Phosphate for Oral Suspension 6 mg/mL* *Each mL contains 6 mg oseltamivir base after constitution. 60 mL (usable volume after constitution) Rx Only NDC 47781-384-26 Distributed by: Alvogen, Inc. Pine Brook, NJ 07058 USA

Batch or Lot Expiration Information

Lot# 484241

Affected Packages Involved in this Recall

47781-384-26 Oseltamivir Phosphate For Oral Suspension

Recall Number: D-0510-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
91 CARTON

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
TRAZODONE HYDROCHLORIDE TABLETS, USP 50MG 100 TABLET 10X10UD; NDC/UPC 0904-6868-61; RX; TABLETS

Batch or Lot Expiration Information

Lot# R01580

Affected Packages Involved in this Recall

0904-6868-61 Trazodone Hydrochloride
0904-6869-61 Trazodone Hydrochloride
0904-7212-61 Trazodone Hydrochloride

Recall Number: D-0527-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
72 cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
Estradiol Transdermal System, USP 0.1 mg/day (Twice-Weekly) Delivers 0.1 mg/day Rx only NDC 0378-4623-26 Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.

Batch or Lot Expiration Information

Lot# 3108206

Affected Packages Involved in this Recall

0378-4619-16 Estradiol
0378-4619-26 Estradiol
0378-4620-16 Estradiol
0378-4620-26 Estradiol
0378-4621-16 Estradiol
0378-4621-26 Estradiol
0378-4622-16 Estradiol
0378-4622-26 Estradiol
0378-4623-16 Estradiol
0378-4623-26 Estradiol

Recall Number: D-0428-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
31 droptainers

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
Timolol Maleate Ophthalmic Solution, USP 0.5% 2.5 mL Sterile For Topical Application In The Eye Rx Only NDC 60505-1005-4 Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, FL 33326

Batch or Lot Expiration Information

Lot# RV7378

Recall Number: D-0450-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
67 BOXES

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
SYMPROIC (NAIDEMEDINE) TABLETS 0.2MG 30 TABLETS; NDC 59385-041-30; RX; TABLETS

Batch or Lot Expiration Information

Lot# 2003060A

Affected Packages Involved in this Recall

59385-041-30 Symproic
59385-041-07 Symproic

Recall Number: D-0461-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
20 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
Valsartan Tablets USP 40 mg 30 Scored Tablets Rx Only NDC 59746-360-30 Manufactured by: Jubilant Generics Ltd. Roorkee-247661, India

Batch or Lot Expiration Information

Lot# VR120022A

Affected Packages Involved in this Recall

59746-360-30 Valsartan
59746-360-90 Valsartan
59746-360-05 Valsartan
59746-360-03 Valsartan
59746-361-30 Valsartan
59746-361-90 Valsartan
59746-361-05 Valsartan
59746-361-03 Valsartan
59746-362-30 Valsartan
59746-362-90 Valsartan
59746-362-05 Valsartan
59746-362-03 Valsartan
59746-363-30 Valsartan
59746-363-90 Valsartan
59746-363-67 Valsartan
59746-363-32 Valsartan

Recall Number: D-0553-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
341 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
Methotrexate Injection, USP 50 mg/2mL (25 mg/mL) 5 x 2mL Single-Dose Vials, Sterile, Rx Only, Distributed by Hospira, Inc. Lake Forest, IL 60045. NDC 61703-350-38.

Batch or Lot Expiration Information

Lot# H074437AA

Affected Packages Involved in this Recall

61703-350-37 Methotrexate
61703-350-38 Methotrexate
61703-408-41 Methotrexate

Recall Number: D-0480-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
353 inhalers

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
Arnuity Ellipta (fluticasone furoate inhalation powder) 200 mcg 1 Ellipta Inhaler containing 1 Foil Strip of 30 Blisters Rx Only NDC 0173-0876-10 GlaxoSmithKline Research Triangle Park, NC 27709

Batch or Lot Expiration Information

Lot# 5U3D

Affected Packages Involved in this Recall

0173-0888-10 Arnuity Ellipta
0173-0874-10 Arnuity Ellipta
0173-0874-14 Arnuity Ellipta
0173-0876-10 Arnuity Ellipta
0173-0876-14 Arnuity Ellipta

Recall Number: D-0529-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
834 aerosol containers

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
Proctofoam HC (hydrocortisone acetate 1% and pramoxine hydrochloride 1%) topical aerosol 10 g net wt Rx Only NDC 0037-6822-10 Distributed by: Meda Pharmaceutical Inc. Somerset, New Jersey

Batch or Lot Expiration Information

Lot# 33119

Affected Packages Involved in this Recall

0037-6822-10 Proctofoam Hc

Recall Number: D-0579-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
23 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
Balziva 28 Day (norethindrone and ethinyl estradiol tablets USP) 6 Blister Card Dispensers, 28 tablets each, Rx Only, Manufactured for: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0555-9034-58

Batch or Lot Expiration Information

Lot# 100016785

Affected Packages Involved in this Recall

0555-9034-79 Balziva
0555-9034-58 Balziva

Recall Number: D-0523-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
299 cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
Belsomra (suvorexant) tablets 20 mg Each tablet contains 20 mg suvorexant. This package contains 30 Tablets in 3 Blister Cards. Each Blister Card contains 10 Tablets. Rx only NDC 0006-0335-30 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. Whitehouse Station, NJ 08880, USA

Batch or Lot Expiration Information

Lot# 1778598

Affected Packages Involved in this Recall

0006-0005-10 Belsomra
0006-0005-30 Belsomra
0006-0005-13 Belsomra
0006-0033-10 Belsomra
0006-0033-30 Belsomra
0006-0033-13 Belsomra
0006-0325-10 Belsomra
0006-0325-30 Belsomra
0006-0325-13 Belsomra
0006-0335-10 Belsomra
0006-0335-30 Belsomra
0006-0335-13 Belsomra

Recall Number: D-0404-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
362 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
Norvir Ritonavir Tablets 100 mg 30 Tablets Rx only NDC 0074-3333-30 Abbott Laboratories North Chicago, IL 60064, U.S.A.

Batch or Lot Expiration Information

Lot# 1131141

Affected Packages Involved in this Recall

0074-3333-30 Norvir
0074-1940-63 Norvir
0074-3399-30 Norvir
0074-2340-30 Norvir

Recall Number: D-0427-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
38 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
Butorphanol Tartrate Nasal Solution USP 10 mg/mL 2. 5 mL bottles Rx Only NDC 60505-0813-1 Mfg by: Apotex Inc. Toronto, Ontario Canada M9L 1T9

Batch or Lot Expiration Information

Lot# RT7113

Affected Packages Involved in this Recall

60505-0813-1 Butorphanol Tartrate

Recall Number: D-0508-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
60 CARTON

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
TRI-LO-MARZIA 0.180MG/0.025MG; 0.215 MG/0.025MG AND 0.250MG/0.025MG 3X28 BPK; NDC/UPC 68180-837-73; RX; TABLETS

Batch or Lot Expiration Information

Lot# L001911

Affected Packages Involved in this Recall

68180-837-73 Tri-lo-marzia

Recall Number: D-0473-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
11189 plungers

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
Narcan (naloxone HCl) Nasal Spray 4 mg Two Pack This box contains two (2) 4-mg doses of naloxone HCl in 0.1 mL of nasal spray. 0.1 mL intranasal spray per unit For use in the nose only Rx only NDC 69547-353-02 Distributed by Adapt Pharma, Inc. Radnor, PA 19087 USA

Batch or Lot Expiration Information

Lot# 201701

Affected Packages Involved in this Recall

69547-353-02 Narcan

Recall Number: D-0407-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
106 BOXES

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
FENOFIBRATE CAPSULES, UPS 67MG 100 CAPSULES NDC/UPC 27241-118-04; RX; CAPSULES

Batch or Lot Expiration Information

Lot# PA03410

Affected Packages Involved in this Recall

27241-118-04 Fenofibrate
27241-118-05 Fenofibrate
27241-119-04 Fenofibrate
27241-119-05 Fenofibrate
27241-120-04 Fenofibrate
27241-120-05 Fenofibrate

Recall Number: D-0520-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
407 BOXES

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
CARBIDOPA AND LEVORDOPA TABLETS, USP 25MG/100MG 100 TABLETS; NDC/UPC 51862-856-01; RX; TABLETS

Batch or Lot Expiration Information

Lot# FG12532

Recall Number: D-0572-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
2907 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
Children's Loratadine Oral Solution USP, 5 mg/5 mL (Antihistamine) Allergy Grape Flavor 4 FL OZ (120 mL) NDC 51672-2131-8 Distributed by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532

Batch or Lot Expiration Information

Lot# All Lots distributed 02/23/2021 through 03/10/2021.

Affected Packages Involved in this Recall

51672-2131-4 Childrens Loratadine Sugar Free
51672-2131-8 Childrens Loratadine Sugar Free
51672-2131-1 Childrens Loratadine Sugar Free

Recall Number: D-0434-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
355 inhalers

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
Bevespi Aerosphere (glycopyrrolate and formoterol fumarate) Inhalation Aerosol 9 mcg/4.8 mcg per inhalation For Oral Inhalation only 120 inhalations Rx Only NDC 0310-4600-12 Mfd for: AstraZeneca Pharmaceuticals, LP, Wilmington, DE 19850

Batch or Lot Expiration Information

Lot# 6030180A00

Affected Packages Involved in this Recall

0310-4600-12 Bevespi Aerosphere
0310-4600-28 Bevespi Aerosphere
0310-4600-39 Bevespi Aerosphere

Recall Number: D-0470-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
1 bottle

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
Phenobarbital Tablets, USP 32.4 mg 100 tablets Rx only NdC 13517-111-01 Manufactured for: e5 Pharma, LLC., Boca Raton, FL 33432

Batch or Lot Expiration Information

Lot# 20ZHX2R

Recall Number: D-0500-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
453 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
Livalo (pitavastatin) tablets 2 mg* Rx Only NdC 66869-204-90 Manufactured under license from: Kowa Company, Limited Tokyo 103-8433 Japan Tablets Manufactured by: Patheon, Inc. Cincinnati, OH 45237 USA or by Kowa Company, Ltd Nagoya 462-0024 Japan

Batch or Lot Expiration Information

Lot# 3193479

Affected Packages Involved in this Recall

66869-104-90 Livalo
66869-204-90 Livalo
66869-204-07 Livalo
66869-404-90 Livalo
66869-404-07 Livalo

Recall Number: D-0551-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
178 tubes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
Triamcinolone Acetonide Ointment, USP, 0.025% 80g; Rx Only, Distributed by: Perrigo, Allegan, MI 49010,NDC 45802-054-36

Batch or Lot Expiration Information

Lot# 0MT0286

Affected Packages Involved in this Recall

45802-054-35 Triamcinolone Acetonide
45802-054-05 Triamcinolone Acetonide
45802-054-36 Triamcinolone Acetonide
45802-055-35 Triamcinolone Acetonide
45802-055-36 Triamcinolone Acetonide
45802-055-05 Triamcinolone Acetonide
45802-049-35 Triamcinolone Acetonide

Recall Number: D-0403-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
210 cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
Orilissa elagolix tablets 150 mg per tablet equivalent to 155.2 mg elagolix sodium, 28 Tablets For 28 Days Rx only NDC 0074-0038-28 Each carton contains 28 tablets in 4 weekly blister pack, Each weekly blister pack contains 7 tablets of elagolix 150 mg AbbVie Inc. North Chicago, IL 60064

Batch or Lot Expiration Information

Lot# 1120778

Affected Packages Involved in this Recall

0074-0038-28 Orilissa
0074-0038-01 Orilissa
0074-0038-07 Orilissa
0074-0039-56 Orilissa
0074-0039-01 Orilissa
0074-0039-14 Orilissa

Recall Number: D-0556-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
1040 cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
Chantix (varenicline) Tablets Starting Pack Contains: 1 Starting Week (0.5 mgx11 tablets) 3 Continuing Weeks (1 mgx42 tablets) Rx only NDC 0069-0471-03 Distributed by Pfizer Labs Division of Pfizer, Inc., NY, NY 10017

Batch or Lot Expiration Information

Lot# EC5911

Affected Packages Involved in this Recall

0069-0468-56 Chantix
0069-0469-56 Chantix
0069-0469-28 Chantix
0069-0471-03 Chantix
0069-0471-28 Chantix

Recall Number: D-0489-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
32 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
bupropion Hydrochloride Tablets, USP 75 mg 100 Tablets Rx only NDC 23155-191-01 Manufactured for: Heritage Pharmaceuticals Inc. Eatontown, NJ 07724

Batch or Lot Expiration Information

Lot# L200791

Affected Packages Involved in this Recall

23155-191-10 Bupropion Hydrochloride
23155-191-01 Bupropion Hydrochloride
23155-192-10 Bupropion Hydrochloride
23155-192-01 Bupropion Hydrochloride

Recall Number: D-0419-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
31 tubes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
Rectiv (nitroglycerin) Ointment 0.4% For Intra-anal Use Only 30 g Rx Only NDC 58914-301-80 Mfd. by: Pharbil Waltrop GmbH, Im Wirrigen 25, 45731 Waltrop, Germany Distributed by: Aptalis Pharma US, Inc. Birmingham, AL 35242

Batch or Lot Expiration Information

Lot# 2399070

Affected Packages Involved in this Recall

58914-301-80 Rectiv
58914-301-85 Rectiv

Recall Number: D-0507-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
24 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
NOHIST-DM Antihistamine/Antitussive Nasal Decongestant 16 fl. oz. (473 mL) NDC 68047-186-16 Distributed by: Larken Laboratories, Inc. Canton, MS 39046

Batch or Lot Expiration Information

Lot# All Lots distributed 02/23/2021 through 03/10/2021.

Affected Packages Involved in this Recall

68047-186-16 Nohist Dm

Recall Number: D-0425-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
325 CARTONS

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
TRAVOPROST OPHTHALMIC SOLUTION, USP 0.004% 2.5ML ; NDC/UPC 60505-0593-4; RX; DROPS

Batch or Lot Expiration Information

Lot# RW4409

Affected Packages Involved in this Recall

60505-0593-4 Travoprost
60505-0593-1 Travoprost

Recall Number: D-0513-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
189 tubes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
Acne Medication Benzoyl Peroxide Gel USP, 5% Net Wt 1.5 oz (42.5 g) NDC 0536-1055-56 Distributed by: Rugby Laboratories 31778 Enterprise Drive, Livonia, MI 48150

Batch or Lot Expiration Information

Lot# All Lots distributed 02/23/2021 through 03/10/2021.

Affected Packages Involved in this Recall

0536-1055-56 Rugby Benzoyl Peroxide Acne Medication
0536-1055-25 Rugby Benzoyl Peroxide Acne Medication
0536-1055-57 Rugby Benzoyl Peroxide Acne Medication

Recall Number: D-0495-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
25 boxes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
TIROSINT(levothyroxine sodium) capsules 175MCG 3 blisters X10 capsules; NDC/UPC 71858-0055-4; RX; CAPSULES

Batch or Lot Expiration Information

Lot# 200606

Affected Packages Involved in this Recall

71858-0013-4 Tirosint
71858-0013-1 Tirosint
71858-0013-2 Tirosint
71858-0012-4 Tirosint
71858-0012-1 Tirosint
71858-0012-2 Tirosint
71858-0005-4 Tirosint
71858-0005-1 Tirosint
71858-0005-2 Tirosint
71858-0010-4 Tirosint
71858-0010-1 Tirosint
71858-0010-2 Tirosint
71858-0015-4 Tirosint
71858-0015-1 Tirosint
71858-0015-2 Tirosint
71858-0020-4 Tirosint
71858-0020-1 Tirosint
71858-0020-2 Tirosint
71858-0025-4 Tirosint
71858-0025-1 Tirosint
71858-0025-2 Tirosint
71858-0030-4 Tirosint
71858-0030-1 Tirosint
71858-0030-2 Tirosint
71858-0035-4 Tirosint
71858-0035-1 Tirosint
71858-0035-2 Tirosint
71858-0040-4 Tirosint
71858-0040-1 Tirosint
71858-0040-2 Tirosint
71858-0045-4 Tirosint
71858-0045-1 Tirosint
71858-0045-2 Tirosint
71858-0050-4 Tirosint
71858-0050-1 Tirosint
71858-0050-2 Tirosint
71858-0055-4 Tirosint
71858-0055-1 Tirosint
71858-0055-2 Tirosint
71858-0060-4 Tirosint
71858-0060-1 Tirosint
71858-0060-2 Tirosint
71858-0017-4 Tirosint
71858-0017-1 Tirosint
71858-0017-2 Tirosint

Recall Number: D-0442-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
255 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
Nuedexta (dextromethorphan HBr and quinidine sulfate) Capsules 20 mg/10 mg 60 capsules Rx only NDC 64597-301-60 Manufactured by Patheon, Inc. Whitby, ON L1N 5Z5, Canada

Batch or Lot Expiration Information

Lot# CFBFP

Affected Packages Involved in this Recall

64597-301-13 Nuedexta
64597-301-60 Nuedexta

Recall Number: D-0449-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
47 cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
Belbuca (buprenorphine hydrochloride) buccal film 600 mcg 60 pouches containing 1 buccal film each Rx only NDC 59385-025-60 Manufactured for: BioDelivery Sciences International, Inc. Raleigh, NC 27612 USA

Batch or Lot Expiration Information

Lot# BL6002004

Affected Packages Involved in this Recall

59385-021-01 Belbuca
59385-021-60 Belbuca
59385-022-01 Belbuca
59385-022-60 Belbuca
59385-023-01 Belbuca
59385-023-60 Belbuca
59385-024-01 Belbuca
59385-024-60 Belbuca
59385-025-01 Belbuca
59385-025-60 Belbuca
59385-026-01 Belbuca
59385-026-60 Belbuca
59385-027-01 Belbuca
59385-027-60 Belbuca

Recall Number: D-0463-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
576 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
Meloxicam Tablets, USP 7.5 mg 100 Tablets Rx Only NDC 69097-158-07 Manufactured for: Cipla USA, Inc. 9100 S. Dadeland Blvd., Suite 1500 Miami, FL 33156

Batch or Lot Expiration Information

Lot# KA03034

Affected Packages Involved in this Recall

69097-158-15 Meloxicam
69097-158-07 Meloxicam
69097-158-12 Meloxicam
69097-159-12 Meloxicam
69097-159-07 Meloxicam
69097-159-15 Meloxicam

Recall Number: D-0535-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
341 CARTON

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
CIPRODEX (CIPROFLOXACIN 0.3 AND DEXAMETHASONE 0.1%) 7.5ML; NDC/UPC 0078-0799-75; RX; DROPS

Batch or Lot Expiration Information

Lot# 20F02UA

Recall Number: D-0550-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
95 suppositories

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
HYDROCORTISONE ACET 30MG 12; RX; SUPPOSITORY,Rx Only, Distributed by: Perrigo, Allegan, MI 49010, NDC: 0574-7093-12

Batch or Lot Expiration Information

Lot# 433202

Affected Packages Involved in this Recall

0574-7090-12 Hydrocortisone Acetate
0574-7093-12 Hydrocortisone Acetate

Recall Number: D-0524-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
215 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
Steglatro (ertugliflozin) tablets 15 mg 30 Tablets Rx only NDC 0006-5364-03 Manuf. for: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Whitehouse Station, NJ 08889, USA

Batch or Lot Expiration Information

Lot# T013566

Affected Packages Involved in this Recall

0006-5363-03 Steglatro
0006-5363-08 Steglatro
0006-5363-09 Steglatro
0006-5363-06 Steglatro
0006-5363-07 Steglatro
0006-5363-10 Steglatro
0006-5364-03 Steglatro
0006-5364-08 Steglatro
0006-5364-09 Steglatro
0006-5364-06 Steglatro
0006-5364-07 Steglatro

Recall Number: D-0518-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
37 BOTTLE

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
BENZOYL PEROXIDE WASH 5% 148ML; NDC/UPC 0536-1259-63; OTC; LIQUID

Batch or Lot Expiration Information

Lot# All Lots distributed 02/23/2021 through 03/10/2021.

Affected Packages Involved in this Recall

0536-1259-19 Rugby Benzoyl Peroxide Wash Acne Medication
0536-1259-63 Rugby Benzoyl Peroxide Wash Acne Medication

Recall Number: D-0453-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
2611 inhalers

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
Spiriva HandiHaler (tiotropium bromide inhalation powder) For Oral Inhalation Only 18 mcg (as tiotropium) per capsule Rx only NDC 0597-0075-41 Manufactured by: Boehringer Ingelheim (BI) Pharma GmbH & Co. KG Ingelheim, Germany Marketed by: Boehringer Ingelheim Pharmaceuticals, Inc. Ridgefield, CT 06877 USA and Pfizer, Inc. New York, NY 10017 USA

Batch or Lot Expiration Information

Lot# 5098

Affected Packages Involved in this Recall

0597-0075-41 Spiriva Handihaler
0597-0075-75 Spiriva Handihaler
0597-0075-47 Spiriva Handihaler

Recall Number: D-0575-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
235 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLETS 2.5 mg/6.25 mg, 100-count bottles, Rx Only, Distributed by: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054 NDC 0093-3241-01 RX; TABLETS

Batch or Lot Expiration Information

Lot# 1417295A

Affected Packages Involved in this Recall

0093-3241-01 Bisoprolol Fumarate And Hydrochlorothiazide
0093-3242-01 Bisoprolol Fumarate And Hydrochlorothiazide
0093-3243-56 Bisoprolol Fumarate And Hydrochlorothiazide

Recall Number: D-0421-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
15 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
Nitrofurantoin Macrocrystals Capsules 25 mg 100 Capsules Rx Only NDC 47781-306-01 Manufactured by: Norwich Pharmaceuticals, Inc. Norwich, NY 13815 Distributed by: Alvogen, Inc. Parsippany, NJ 07054 U.S.A.

Batch or Lot Expiration Information

Lot# 486942

Affected Packages Involved in this Recall

47781-306-01 Nitrofurantoin Macrocrystals
47781-307-01 Nitrofurantoin Macrocrystals
47781-308-01 Nitrofurantoin Macrocrystals

Recall Number: D-0554-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
940 cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
Chantix (varenicline) Tablets Continuing Month Box Contains: 4 Continuing Weeks (1 mg x 56 tablets) Rx only NDC 0069-0469-03 Distributed by Pfizer Labs Division of Pfizer Inc., NY, NY 10017

Batch or Lot Expiration Information

Lot# EC5910

Recall Number: D-0483-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
513 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
Verapamil Hydrochloride Extended-Release Tablets USP 120 mg Rx Only NDC 68462-292-01 Manufactured by: Glenmark Generics Ltd Colvale-Bardez, Goa 403513, India Manufactured for: Glenmark Generics Inc., USA Mahwah, NJ 07430

Batch or Lot Expiration Information

Lot# 19205584

Affected Packages Involved in this Recall

68462-292-90 Verapamil Hydrochloride
68462-292-01 Verapamil Hydrochloride
68462-292-05 Verapamil Hydrochloride
68462-293-90 Verapamil Hydrochloride
68462-293-01 Verapamil Hydrochloride
68462-293-05 Verapamil Hydrochloride
68462-260-30 Verapamil Hydrochloride
68462-260-90 Verapamil Hydrochloride
68462-260-01 Verapamil Hydrochloride
68462-260-05 Verapamil Hydrochloride
68462-260-10 Verapamil Hydrochloride

Recall Number: D-0424-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
135 CARTON

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
ERYTHROMYCIN TABLETS, USP 250MG 30; NDC/UPC 69238-1484-3; RX; TABLETS

Batch or Lot Expiration Information

Lot# AM200540

Recall Number: D-0455-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
592 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
Glyxambi (empagliflozin and linagliptin) Tablets 25 mg/5 mg 30 tablets Rx only NDC 0597-0164-30 Dist. by: Boehringer Ingelheim (BI) Pharmaceuticals, Inc. Ridgefield, CT 06877 USA

Batch or Lot Expiration Information

Lot# 3513

Affected Packages Involved in this Recall

0597-0182-70 Glyxambi
0597-0182-07 Glyxambi
0597-0182-03 Glyxambi
0597-0182-30 Glyxambi
0597-0182-39 Glyxambi
0597-0182-90 Glyxambi
0597-0164-30 Glyxambi
0597-0164-39 Glyxambi
0597-0164-90 Glyxambi
0597-0164-70 Glyxambi
0597-0164-07 Glyxambi

Recall Number: D-0458-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
269 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
Synjardy XR (empagliflozin and metformin hydrochloride extended-release) Tablets 25 mg/1000 mg 30 tablets Rx only NDC 0597-0295-88 Dist. by: Boehringer Ingelheim (BI) Pharmaceuticals, Inc., Ridgefield, CT 06877 USA

Batch or Lot Expiration Information

Lot# 3191432

Affected Packages Involved in this Recall

0597-0280-36 Synjardy Xr
0597-0280-73 Synjardy Xr
0597-0280-90 Synjardy Xr
0597-0290-20 Synjardy Xr
0597-0290-59 Synjardy Xr
0597-0290-74 Synjardy Xr
0597-0295-61 Synjardy Xr
0597-0295-78 Synjardy Xr
0597-0295-88 Synjardy Xr
0597-0300-20 Synjardy Xr
0597-0300-45 Synjardy Xr
0597-0300-93 Synjardy Xr

Recall Number: D-0568-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
223 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
CLINDAMYCIN HYDROCHLORIDE CAPSULES, USP,150MG 100-count bottles, Rx Only, Manufactured by: Ohm Laboratories Inc. New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, NDC 63304-692-01

Batch or Lot Expiration Information

Lot# AB77104

Affected Packages Involved in this Recall

63304-692-01 Clindamycin Hydrochloride
63304-692-05 Clindamycin Hydrochloride
63304-692-77 Clindamycin Hydrochloride
63304-692-03 Clindamycin Hydrochloride
63304-693-16 Clindamycin Hydrochloride
63304-693-01 Clindamycin Hydrochloride
63304-693-03 Clindamycin Hydrochloride
63304-693-05 Clindamycin Hydrochloride
63304-693-77 Clindamycin Hydrochloride
63304-693-11 Clindamycin Hydrochloride
63304-693-62 Clindamycin Hydrochloride

Recall Number: D-0592-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
271 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
Amantadine Hydrochloride Tablets 100 mg 100-count bottle, Rx Only Manufactured by Upsher-Smith Laboratories, Inc. Maple Grove, MN 55369, NDC 0832-0111-00

Batch or Lot Expiration Information

Lot# 395310

Affected Packages Involved in this Recall

0832-0111-00 Amantadine Hydrochloride
0832-0111-50 Amantadine Hydrochloride
0832-0111-89 Amantadine Hydrochloride
0832-0111-03 Amantadine Hydrochloride

Recall Number: D-0536-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
1189 cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
Rybelsus (semaglutide) Tablets 7 mg Once daily Each tablet contains 7 mg semaglutide 30 tablets 3 blister packs. Each pack contains 10 tablets. Rx only NDC 0169-4307-13 Manufactured by: Novo Nordisk A/S DK-2880 Bagsvaerd, Denmark

Batch or Lot Expiration Information

Lot# K082347

Affected Packages Involved in this Recall

0169-1715-30 Ozempic
0169-1715-90 Ozempic
0169-1704-30 Ozempic
0169-1709-30 Ozempic
0169-4303-01 Rybelsus
0169-4303-13 Rybelsus
0169-4303-90 Rybelsus
0169-4303-93 Rybelsus
0169-4303-30 Rybelsus
0169-4303-99 Rybelsus
0169-4307-01 Rybelsus
0169-4307-13 Rybelsus
0169-4307-30 Rybelsus
0169-4314-01 Rybelsus
0169-4314-13 Rybelsus
0169-4314-30 Rybelsus
0169-4815-30 Rybelsus
0169-4815-90 Rybelsus
0169-4804-30 Rybelsus
0169-4809-30 Rybelsus

Recall Number: D-0512-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
88 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
Banophen Diphenhydramine HCl 25 mg Antihistamine 100 capsules NDC 0904-5306-60 Distributed by: Major Pharmaceuticals 31778 Enterprise Drive Livonia, MI 48150 USA

Batch or Lot Expiration Information

Lot# All Lots distributed 02/23/2021 through 03/10/2021

Affected Packages Involved in this Recall

0904-5306-60 Diphenhydramine Hydrochloride
0904-5306-80 Diphenhydramine Hydrochloride
0904-5306-61 Diphenhydramine Hydrochloride
0904-5306-24 Diphenhydramine Hydrochloride
0904-2056-61 Diphenhydramine Hydrochloride
0904-2035-24 Banophen

Recall Number: D-0418-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
659 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
Namzaric (memantine HCl extended release and donepezil HCl) capsules 14 mg/10 mg per capsule 30 capsules Rx Only NDC 0456-1214-30 Distributed by Forest Pharmaceuticals, Inc. Subsidiary of Forest Laboratories, LLC.

Batch or Lot Expiration Information

Lot# W04815

Affected Packages Involved in this Recall

0456-1207-30 Namzaric
0456-1214-11 Namzaric
0456-1214-30 Namzaric
0456-1214-63 Namzaric
0456-1214-90 Namzaric
0456-1221-30 Namzaric
0456-1228-30 Namzaric
0456-1228-90 Namzaric
0456-1228-63 Namzaric
0456-1228-11 Namzaric
0456-1229-29 Namzaric
0456-1229-04 Namzaric

Recall Number: D-0499-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
136 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
Auryxia (ferric citrate) tablets 210 mg* 200 Tablets Rx Only NDC 59922-631-01 Manufactured for and distributed by: Keryx Biopharmaceuticals, Inc. 750 Lexington Avenue, 20th Floor New York, NY 10022 USA

Batch or Lot Expiration Information

Lot# AN0142D

Affected Packages Involved in this Recall

59922-631-01 Auryxia

Recall Number: D-0581-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
57 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
Desvenlafaxine Extended-Release Tablets 25 mg 30 Tablets Rx Only NDC 0591-4060-30 Manufactured by: Actavis Laboratories FL, Inc. Fort Lauderdale, FL 33314 USA Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA

Batch or Lot Expiration Information

Lot# 1399650A

Affected Packages Involved in this Recall

0591-4060-30 Desvenlafaxine
0591-3659-30 Desvenlafaxine
0591-3660-30 Desvenlafaxine

Recall Number: D-0417-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
1529 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
Linzess (linaclotide) capsules 72 mcg/capsule 30 capsules Rx Only NDC 0456-1203-30 Distributed by: Allergan USA, Inc. Irvine, CA 92612

Batch or Lot Expiration Information

Lot# W04411

Affected Packages Involved in this Recall

0456-1201-30 Linzess
0456-1201-04 Linzess
0456-1201-07 Linzess
0456-1202-30 Linzess
0456-1202-04 Linzess
0456-1202-07 Linzess
0456-1203-30 Linzess
0456-1203-04 Linzess
0456-1203-07 Linzess

Recall Number: D-0486-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
2264 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
Triumeq (abacavir, dolutegravir, and lamivudine) 600 mg/50 mg/300 mg Tablets 30 Tablets Rx Only NDC 49702-231-13 Manufactured for: Viiv Healthcare Research Triangle Park, NC 27709 by GlaxoSmithKline Research Triangle Park, NC 27709

Batch or Lot Expiration Information

Lot# GS5G

Affected Packages Involved in this Recall

49702-231-13 Triumeq
49702-258-37 Triumeq Pd

Recall Number: D-0564-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
8 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
Cefazolin for Injection, USP 1 gram per vial Rx Only Single-use Vial Sterile Manufactured in Austria by Sandoz GmbH for Sandoz, Inc., Princeton, NJ 08540, NDC 0781-3451-70

Batch or Lot Expiration Information

Lot# JZ9830

Affected Packages Involved in this Recall

0781-3450-70 Cefazolin
0781-3450-95 Cefazolin
0781-3451-70 Cefazolin
0781-3451-96 Cefazolin
0781-3451-95 Cefazolin

Recall Number: D-0436-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
378 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
xigduo XR (dapagliflozin/metformin HCl extended-release) tablets 5 mg/1000 mg 60 Tablets Rx only NDC 0310-6260-60 Manufactured for: AstraZeneca Pharmaceuticals LP Wilmington, DE 19850

Batch or Lot Expiration Information

Lot# ML0171

Affected Packages Involved in this Recall

0310-6270-30 Xigduo Xr
0310-6270-95 Xigduo Xr
0310-6280-30 Xigduo Xr
0310-6280-95 Xigduo Xr
0310-6250-30 Xigduo Xr
0310-6250-95 Xigduo Xr
0310-6260-30 Xigduo Xr
0310-6260-60 Xigduo Xr
0310-6260-94 Xigduo Xr
0310-6260-95 Xigduo Xr
0310-6225-60 Xigduo Xr
0310-6225-94 Xigduo Xr

Recall Number: D-0584-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
37 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
Darifenacin Extended-release Tablets 15 mg 30 Tablets Rx only, Manufactured by: Torrent Pharmaceuticals, LTD Indrad-382 721, India Manufactured for: Torrent Pharma Inc. Basking Ridge, NJ 07920, NDC 13668-203-30

Batch or Lot Expiration Information

Lot# BDZ9G005

Affected Packages Involved in this Recall

13668-202-30 Darifenacin
13668-202-90 Darifenacin
13668-202-05 Darifenacin
13668-203-30 Darifenacin
13668-203-05 Darifenacin
13668-203-90 Darifenacin

Recall Number: D-0496-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
11 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
Enbrace HR 30 ct. Softgels Enhanced Prenatal Vitamin Supplement Rx NDC 64661-650-30 Manufactured for: JAYMAC Pharmaceuticals, LLC, Sunset, LA 70584

Batch or Lot Expiration Information

Lot# All Lots distributed 02/23/2021 through 03/10/2021.

Affected Packages Involved in this Recall

64661-650-30 Enbrace Hr

Recall Number: D-0485-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
141 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
Theophylline (Anhydrous) Extended-Release Tablets 400 mg 100 Tablets Rx Only NDC 68462-380-01 Manufactured by: Glenmark Pharmaceuticals Limited Colvale-Bardez, Goa 403513, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430

Batch or Lot Expiration Information

Lot# 19205025

Affected Packages Involved in this Recall

68462-380-01 Theophylline
68462-380-05 Theophylline
68462-356-01 Theophylline
68462-356-05 Theophylline

Recall Number: D-0476-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
1473 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
cathflo activase (ALTEPLASE) 2 mg Rx Only NDC 50242-041-64 Genentech

Batch or Lot Expiration Information

Lot# 3410425

Affected Packages Involved in this Recall

50242-041-64 Cathflo Activase
50242-041-10 Cathflo Activase

Recall Number: D-0583-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
52 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
Darifenacin Extended-release Tablets 7.5 mg 30 Tablets Rx only Manufactured by: Torrent Pharmaceuticals LTD. Indrad-382 721, India Manufactured for: Torrent Pharma Inc. Basking Ridge, NJ 07920, NDC 13668-202-30

Batch or Lot Expiration Information

Lot# BDZ7G005

Affected Packages Involved in this Recall

13668-202-30 Darifenacin
13668-202-90 Darifenacin
13668-202-05 Darifenacin
13668-203-30 Darifenacin
13668-203-05 Darifenacin
13668-203-90 Darifenacin

Recall Number: D-0590-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
882 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
VIMPAT (lacosamide) Tablets, 200mg, 60-count bottle, Rx Only, Manufactured for: UCB, Inc. Smyrna, GA 30080, NDC 0131-2480-35

Batch or Lot Expiration Information

Lot# 912064

Affected Packages Involved in this Recall

0131-2477-35 Vimpat
0131-2477-60 Vimpat
0131-2477-99 Vimpat
0131-2478-35 Vimpat
0131-2478-60 Vimpat
0131-2478-99 Vimpat
0131-2479-35 Vimpat
0131-2479-60 Vimpat
0131-2479-99 Vimpat
0131-2480-35 Vimpat
0131-2480-60 Vimpat
0131-2480-99 Vimpat
0131-1810-67 Vimpat
0131-5410-70 Vimpat
0131-5410-71 Vimpat
0131-5410-72 Vimpat

Recall Number: D-0482-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
903 inhalers

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
Trelegy Ellipta (fluticasone furoate, umeclidinium, and vilanterol inhalation powder) 100 mcg/62.5 mcg/25 mcg; 1 ELLIPTA Inhaler containing 30 doses (60 blisters total) Rx Only NDC 0173-0887-10 GlaxoSmithKline Research Triangle Park, NC 27709

Batch or Lot Expiration Information

Lot# 3X8P

Affected Packages Involved in this Recall

0173-0887-10 Trelegy Ellipta
0173-0887-14 Trelegy Ellipta
0173-0887-61 Trelegy Ellipta
0173-0893-10 Trelegy Ellipta
0173-0893-14 Trelegy Ellipta
0173-0893-61 Trelegy Ellipta

Recall Number: D-0570-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
490 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
Trokendi XR (topiramate) extended-release capsules 100 mg 30 Capsules Rx only, Manufactured by: Catalent Pharma Solutions Winchester, KY 40391 USA Manufactured for: Supernus Pharmaceuticals, Inc. Rockville, MD 20850 USA, NDC 17772-103-30

Batch or Lot Expiration Information

Lot# 1741214

Affected Packages Involved in this Recall

17772-102-70 Trokendi Xr
17772-102-01 Trokendi Xr
17772-102-30 Trokendi Xr
17772-102-15 Trokendi Xr
17772-102-10 Trokendi Xr
17772-102-12 Trokendi Xr
17772-102-07 Trokendi Xr
17772-103-70 Trokendi Xr
17772-103-01 Trokendi Xr
17772-103-30 Trokendi Xr
17772-103-15 Trokendi Xr
17772-103-10 Trokendi Xr
17772-103-12 Trokendi Xr
17772-103-07 Trokendi Xr
17772-104-70 Trokendi Xr
17772-104-01 Trokendi Xr
17772-104-30 Trokendi Xr
17772-104-15 Trokendi Xr
17772-104-12 Trokendi Xr
17772-104-10 Trokendi Xr
17772-104-07 Trokendi Xr
17772-101-70 Trokendi Xr
17772-101-01 Trokendi Xr
17772-101-30 Trokendi Xr
17772-101-15 Trokendi Xr
17772-101-10 Trokendi Xr
17772-101-12 Trokendi Xr
17772-101-07 Trokendi Xr

Recall Number: D-0402-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
1669 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
Creon (pancrelipase) Delayed-Release Capsules Dose By Lipase Units Lipase 36,000 USP Units Rx only NDC 0032-3016-13 100 Capsules Marketed by: AbbVie Inc. North Chicago, IL 60064, U.S.A.

Batch or Lot Expiration Information

Lot# 1139494

Affected Packages Involved in this Recall

0032-1203-70 Creon
0032-1203-64 Creon
0032-1206-07 Creon
0032-1206-01 Creon
0032-1206-56 Creon
0032-1212-07 Creon
0032-1212-01 Creon
0032-1212-46 Creon
0032-1212-13 Creon
0032-1224-07 Creon
0032-1224-01 Creon
0032-1224-46 Creon
0032-3016-28 Creon
0032-3016-13 Creon
0032-3016-50 Creon
0032-3016-12 Creon
0032-0045-70 Creon
0032-0045-30 Creon
0032-0046-30 Creon
0032-0046-70 Creon
0032-0047-30 Creon
0032-0047-70 Creon
0032-2636-70 Creon
0032-2636-01 Creon
0032-2636-30 Creon
0032-2637-70 Creon
0032-2637-01 Creon
0032-2637-30 Creon

Recall Number: D-0474-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
73 carton

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE SYRUP 10-30-2MG/5ML 473ML; NDC/UPC 71930-026-43; RX; SYRUP

Batch or Lot Expiration Information

Lot# 13120103A

Affected Packages Involved in this Recall

71930-026-18 Brompheniramine Maleate, Pseudoephedrine Hydrochloride,
71930-026-43 Brompheniramine Maleate, Pseudoephedrine Hydrochloride,

Recall Number: D-0437-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
345 CARTONS

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
IBUPROFEN ORAL SUSPENSION USP 100MG/5ML 120ML ; NDC/UPC 59651-032-12; RX; SUSPENSION (NO DROPS)

Batch or Lot Expiration Information

Lot# BO1020069-A

Affected Packages Involved in this Recall

59651-032-12 Ibuprofen
59651-032-47 Ibuprofen

Recall Number: D-0451-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
1240 CARTON

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
NURTEC ODT (RIMEGEPANT) 75MG 8 BPK; NDC/UPC 72618-3000-2; RX; TABLETS FOR RAPID DISSOLUTION (NOT SUBLINGUAL)

Batch or Lot Expiration Information

Lot# 4170326

Affected Packages Involved in this Recall

72618-3000-2 Nurtec Odt
72618-3001-1 Nurtec Odt
72618-3001-2 Nurtec Odt

Recall Number: D-0490-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
122 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
AcetaZOLAMIDE Tablets, USP 125 mg 100 Tablets Rx only NDC 23155-287-01 Manufactured for: Heritage Pharmaceuticals Inc. Eatontown, NJ 07724

Batch or Lot Expiration Information

Lot# M200833

Affected Packages Involved in this Recall

23155-287-10 Acetazolamide
23155-287-01 Acetazolamide
23155-288-01 Acetazolamide
23155-288-10 Acetazolamide

Recall Number: D-0484-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
7 CARTON

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
EZETIMIBE AND SIMVASTATIN TABLETS 10-10MG 30; NDC/UPC 68462-321-30; RX; TABLETS

Batch or Lot Expiration Information

Lot# 17201603

Affected Packages Involved in this Recall

68462-321-90 Ezetimibe And Simvastatin
68462-321-10 Ezetimibe And Simvastatin
68462-321-30 Ezetimibe And Simvastatin
68462-322-30 Ezetimibe And Simvastatin
68462-322-90 Ezetimibe And Simvastatin
68462-322-10 Ezetimibe And Simvastatin
68462-323-30 Ezetimibe And Simvastatin
68462-323-90 Ezetimibe And Simvastatin
68462-323-05 Ezetimibe And Simvastatin
68462-324-30 Ezetimibe And Simvastatin
68462-324-90 Ezetimibe And Simvastatin
68462-324-05 Ezetimibe And Simvastatin

Recall Number: D-0459-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
751 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
Synjardy XR (empagliflozin and metformin) hydrochloride extended-release) Tablets 12.5 mg/1000 mg 60 tablets Rx only NDC 0597-0300-45 Dist. by: Boehringer Ingelheim (BI) Pharmaceuticals, Inc. Ridgefield, CT 06877 USA

Batch or Lot Expiration Information

Lot# 3190949

Affected Packages Involved in this Recall

0597-0280-36 Synjardy Xr
0597-0280-73 Synjardy Xr
0597-0280-90 Synjardy Xr
0597-0290-20 Synjardy Xr
0597-0290-59 Synjardy Xr
0597-0290-74 Synjardy Xr
0597-0295-61 Synjardy Xr
0597-0295-78 Synjardy Xr
0597-0295-88 Synjardy Xr
0597-0300-20 Synjardy Xr
0597-0300-45 Synjardy Xr
0597-0300-93 Synjardy Xr

Recall Number: D-0412-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
71 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
Metoprolol Tartrate and Hydrochlorothiazide Tablets, USP 50 mg/25 mg 100 Tablets Rx only NDC 62332-115-31 Manufactured for: Alembic Pharmaceuticals, Inc. 750 Route 202, Bridgewater, NJ 08807 USA

Batch or Lot Expiration Information

Lot# 2005005745

Affected Packages Involved in this Recall

62332-115-30 Metoprolol Tartrate And Hydrochlorothiazide
62332-115-31 Metoprolol Tartrate And Hydrochlorothiazide
62332-115-91 Metoprolol Tartrate And Hydrochlorothiazide
62332-116-30 Metoprolol Tartrate And Hydrochlorothiazide
62332-116-31 Metoprolol Tartrate And Hydrochlorothiazide
62332-116-71 Metoprolol Tartrate And Hydrochlorothiazide
62332-117-30 Metoprolol Tartrate And Hydrochlorothiazide
62332-117-31 Metoprolol Tartrate And Hydrochlorothiazide
62332-117-71 Metoprolol Tartrate And Hydrochlorothiazide

Recall Number: D-0591-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
101 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
Briviact (brivaracetam) tablets 50 mg, 60-count bottle, Rx only Manufactured for UCB, Inc. Smyrna, GA 30080, NDC 50474-570-66

Batch or Lot Expiration Information

Lot# 309750

Affected Packages Involved in this Recall

50474-470-66 Briviact
50474-470-09 Briviact
50474-470-14 Briviact
50474-370-66 Briviact
50474-570-66 Briviact
50474-570-09 Briviact
50474-570-14 Briviact
50474-670-66 Briviact
50474-770-66 Briviact
50474-770-09 Briviact
50474-770-14 Briviact
50474-870-15 Briviact
50474-970-63 Briviact
50474-970-75 Briviact

Recall Number: D-0571-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
160 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
Colcrys (colchicine, USP) tablets 0.6 mg 30 tablets Rx only Distributed by: Takeda Pharmaceuticals America, Inc. Deerfield, IL 60015,NDC 64764-119-07

Batch or Lot Expiration Information

Lot# 11888415

Recall Number: D-0538-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
131 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
Lamotrigine Extended-Release Tablets 250 mg 30 Tablets Rx Only NDC 49884-604-11 Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Zhejiang 317024 China For Par Pharmaceutical Companes, Inc. Spring Valley, NY 10977 U.S.A.

Batch or Lot Expiration Information

Lot# 10116

Affected Packages Involved in this Recall

49884-561-11 Lamotrigine Extended Release
49884-561-01 Lamotrigine Extended Release
49884-561-05 Lamotrigine Extended Release
49884-562-11 Lamotrigine Extended Release
49884-562-01 Lamotrigine Extended Release
49884-562-05 Lamotrigine Extended Release
49884-563-11 Lamotrigine Extended Release
49884-563-01 Lamotrigine Extended Release
49884-563-05 Lamotrigine Extended Release
49884-564-11 Lamotrigine Extended Release
49884-564-01 Lamotrigine Extended Release
49884-564-05 Lamotrigine Extended Release
49884-604-11 Lamotrigine Extended Release
49884-604-01 Lamotrigine Extended Release
49884-604-05 Lamotrigine Extended Release
49884-605-11 Lamotrigine Extended Release
49884-605-01 Lamotrigine Extended Release
49884-605-05 Lamotrigine Extended Release

Recall Number: D-0481-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
4065 CARTON

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
TRELEGY ELLIPTA (FLUTICASONE FUROATE, UMEDIDINIUM AND VILANTEROL INHALATION POWDER) 100-62.5-25MCG 60; NDC/UPC 0173-0893-10; RX; INHALER MEDICAL INTERNAL - MAY OR MAY NOT BE AEROSOL

Batch or Lot Expiration Information

Lot# FN2J

Affected Packages Involved in this Recall

0173-0887-10 Trelegy Ellipta
0173-0887-14 Trelegy Ellipta
0173-0887-61 Trelegy Ellipta
0173-0893-10 Trelegy Ellipta
0173-0893-14 Trelegy Ellipta
0173-0893-61 Trelegy Ellipta

Recall Number: D-0457-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
52 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
Jentadueto XR (linagliptin and metformin hydrochloride extended-release) Tablets 5 mg/1000 mg 30 tablets Rx only NDC 0597-0275-33 Dist. by: Boehringer Ingleheim (BI) Pharmaceuticals, Inc. Ridgefield, CT 06877 USA

Batch or Lot Expiration Information

Lot# 3189866

Affected Packages Involved in this Recall

0597-0270-12 Jentadueto Xr
0597-0270-73 Jentadueto Xr
0597-0270-94 Jentadueto Xr
0597-0275-33 Jentadueto Xr
0597-0275-81 Jentadueto Xr
0597-0275-88 Jentadueto Xr

Recall Number: D-0509-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
33 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
Amlodipine and Olmesartan Medoxomil Tablets 10 mg/20 mg 30 Tablets Rx Only NDC 33342-192-07 Manufactured for: Macleods Pharma USA, Inc. Plainsboro, NJ 08536 Manufactured by: Macleods Pharmaceuticals Ltd. Baddi, Himachal Pradesh, India

Batch or Lot Expiration Information

Lot# BAD62005A

Affected Packages Involved in this Recall

33342-190-07 Amlodipine And Olmesartan Medoxomil
33342-190-10 Amlodipine And Olmesartan Medoxomil
33342-190-12 Amlodipine And Olmesartan Medoxomil
33342-190-44 Amlodipine And Olmesartan Medoxomil
33342-191-07 Amlodipine And Olmesartan Medoxomil
33342-191-10 Amlodipine And Olmesartan Medoxomil
33342-191-12 Amlodipine And Olmesartan Medoxomil
33342-191-44 Amlodipine And Olmesartan Medoxomil
33342-192-07 Amlodipine And Olmesartan Medoxomil
33342-192-10 Amlodipine And Olmesartan Medoxomil
33342-192-12 Amlodipine And Olmesartan Medoxomil
33342-192-44 Amlodipine And Olmesartan Medoxomil
33342-193-07 Amlodipine And Olmesartan Medoxomil
33342-193-10 Amlodipine And Olmesartan Medoxomil
33342-193-12 Amlodipine And Olmesartan Medoxomil
33342-193-44 Amlodipine And Olmesartan Medoxomil

Recall Number: D-0566-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
406 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
Tuberculin Purified Protein Derivative (Mantous) TUBERSOL, Stabilized Solution 5 US Units, Rx Only Sanofi Pasteur Limited, NDC 49281-752-21

Batch or Lot Expiration Information

Lot# C5804AA

Affected Packages Involved in this Recall

49281-752-78 Tubersol
49281-752-21 Tubersol
49281-752-98 Tubersol
49281-752-22 Tubersol

Recall Number: D-0435-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
664 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
xigduo XR (dapgliflozin/metformin HCl extended-release) tablets 10 mg/1000 mg 30 Tablets Rx only NDC 0310-6280-30 Manufactured for: AstraZeneca Pharmaceuticals LP Wilmington, DE 19850 Manufactured by: Bristol-Myers Squibb Manufacturing Company Humacao, Puerto Rico 00791

Batch or Lot Expiration Information

Lot# MP0077

Affected Packages Involved in this Recall

0310-6270-30 Xigduo Xr
0310-6270-95 Xigduo Xr
0310-6280-30 Xigduo Xr
0310-6280-95 Xigduo Xr
0310-6250-30 Xigduo Xr
0310-6250-95 Xigduo Xr
0310-6260-30 Xigduo Xr
0310-6260-60 Xigduo Xr
0310-6260-94 Xigduo Xr
0310-6260-95 Xigduo Xr
0310-6225-60 Xigduo Xr
0310-6225-94 Xigduo Xr

Recall Number: D-0561-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
905 inhalers

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
Budesonide and Formoterol Fumarate Dihydrate Inhalation Aerosol 80/4.5 budesonide 80 mcg/formoterol fumarate dihydrate 4.5 mcg Inhalation Aerosol 120 inhalations Rx only Manufactured for: AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850, NDC 0310-7372-20

Batch or Lot Expiration Information

Lot# 2000655C00

Affected Packages Involved in this Recall

0310-7370-20 Budesonide And Formoterol Fumarate Dihydrate
0310-7372-20 Budesonide And Formoterol Fumarate Dihydrate

Recall Number: D-0469-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
6 CONTAINERS

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
PREGABALIN CAPSULES 300MG 90 ; NDC 43598-298-90; RX; CAPSULES

Batch or Lot Expiration Information

Lot# T2000309

Affected Packages Involved in this Recall

43598-291-90 Pregabalin
43598-291-05 Pregabalin
43598-291-79 Pregabalin
43598-291-66 Pregabalin
43598-291-78 Pregabalin
43598-292-90 Pregabalin
43598-292-05 Pregabalin
43598-292-79 Pregabalin
43598-292-66 Pregabalin
43598-292-78 Pregabalin
43598-293-90 Pregabalin
43598-293-05 Pregabalin
43598-293-79 Pregabalin
43598-293-66 Pregabalin
43598-293-78 Pregabalin
43598-294-90 Pregabalin
43598-294-05 Pregabalin
43598-294-79 Pregabalin
43598-294-66 Pregabalin
43598-294-78 Pregabalin
43598-295-90 Pregabalin
43598-295-05 Pregabalin
43598-295-79 Pregabalin
43598-295-66 Pregabalin
43598-295-78 Pregabalin
43598-296-90 Pregabalin
43598-296-05 Pregabalin
43598-296-79 Pregabalin
43598-296-66 Pregabalin
43598-296-78 Pregabalin
43598-297-90 Pregabalin
43598-297-05 Pregabalin
43598-297-79 Pregabalin
43598-297-66 Pregabalin
43598-297-78 Pregabalin
43598-298-90 Pregabalin
43598-298-05 Pregabalin
43598-298-79 Pregabalin
43598-298-66 Pregabalin
43598-298-78 Pregabalin

Recall Number: D-0433-2021

Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
03-15-2021
Reported
06-02-2021
Quantity
1278 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87512
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the product.
Brilinta ticagrelar tablets 60 mg 60 tablets Rx only NDC 0186-0776-60 Mfd. for: AstraZeneca LP, Wilmington, DE 19850

Batch or Lot Expiration Information

Lot# MP0138

Affected Packages Involved in this Recall

0186-0777-08 Brilinta
0186-0777-60 Brilinta
0186-0777-18 Brilinta
0186-0777-39 Brilinta
0186-0777-28 Brilinta
0186-0776-60 Brilinta
0186-0776-94 Brilinta