Multi-event January 2022 FDA Recall Warfarin Sodium by Cardinal Healthcare

This Multi-event Class II drug recall was voluntarily initiated by Cardinal Healthcare on January 26, 2022 for the product Warfarin Sodium. The FDA reported the reason for recall as cgmp deviations. The product was distributed Nationwide and the recall is currently terminated.

Reported Recall Events

D-0176-2024 TERMINATED D-0183-2024 TERMINATED D-0187-2024 TERMINATED D-0196-2024 TERMINATED D-0163-2024 TERMINATED D-0178-2024 TERMINATED D-0169-2024 TERMINATED D-0175-2024 TERMINATED D-0199-2024 TERMINATED D-0181-2024 TERMINATED D-0171-2024 TERMINATED D-0172-2024 TERMINATED D-0198-2024 TERMINATED D-0192-2024 TERMINATED D-0174-2024 TERMINATED D-0161-2024 TERMINATED D-0173-2024 TERMINATED D-0201-2024 TERMINATED D-0195-2024 TERMINATED D-0190-2024 TERMINATED D-0200-2024 TERMINATED D-0179-2024 TERMINATED D-0189-2024 TERMINATED D-0170-2024 TERMINATED D-0177-2024 TERMINATED D-0164-2024 TERMINATED D-0166-2024 TERMINATED D-0182-2024 TERMINATED D-0180-2024 TERMINATED D-0184-2024 TERMINATED D-0197-2024 TERMINATED D-0165-2024 TERMINATED D-0191-2024 TERMINATED D-0168-2024 TERMINATED D-0185-2024 TERMINATED D-0186-2024 TERMINATED D-0167-2024 TERMINATED D-0194-2024 TERMINATED D-0162-2024 TERMINATED D-0188-2024 TERMINATED D-0193-2024 TERMINATED D-0202-2024 TERMINATED

Recall Number: D-0176-2024

Reason for Recall
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Initiated
01-26-2022
Reported
01-03-2024
Quantity
1 unit

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89450
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 HEALTHCARE
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.
Nationwide USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-29-2024
Product Description About Product Description
Full technical description of the product.
Donepezil HCl Tablets, 10 mg, 90 Tablets, Rx only, Distributed by: Solco Healthcare U.S. LLC, Hurracao, Puerto Rico 00791. NDC: 43547-276-09

Batch or Lot Expiration Information

Batch# Batch 17616

Affected Packages Involved in this Recall

43547-275-03 Donepezil Hydrochloride
43547-275-09 Donepezil Hydrochloride
43547-275-11 Donepezil Hydrochloride
43547-276-03 Donepezil Hydrochloride
43547-276-09 Donepezil Hydrochloride
43547-276-11 Donepezil Hydrochloride

Recall Number: D-0183-2024

Reason for Recall
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Initiated
01-26-2022
Reported
01-03-2024
Quantity
1 unit

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89450
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 HEALTHCARE
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.
Nationwide USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-29-2024
Product Description About Product Description
Full technical description of the product.
FOLIC ACID TABLETS, USP, 1MG, 100 Tablets per bottle, Rx Only, Manufactured by: Leading Pharma, LLC, Fairfield, NJ 07004. NDC: 69315-127-10

Batch or Lot Expiration Information

Batch# Batch H08221

Affected Packages Involved in this Recall

69315-127-01 Folic Acid
69315-127-10 Folic Acid

Recall Number: D-0187-2024

Reason for Recall
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Initiated
01-26-2022
Reported
01-03-2024
Quantity
1 unit

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89450
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 HEALTHCARE
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.
Nationwide USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-29-2024
Product Description About Product Description
Full technical description of the product.
Lillow (Levonorgestrel and Ethinyl Estradiol Tablets, USP), 0.15 mg/0.03 mg, 1 Blister Pack Containing 28 Tablets, Rx only, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807. NDC 69238-1554-6

Batch or Lot Expiration Information

Batch# Batch A5921

Recall Number: D-0196-2024

Reason for Recall
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Initiated
01-26-2022
Reported
01-03-2024
Quantity
1 unit

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89450
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 HEALTHCARE
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.
Nationwide USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-29-2024
Product Description About Product Description
Full technical description of the product.
RIVASTIGMINE TRANSDERMAL SYSTEM, Delivers 4.6 mg/24 hours, 30 systems per box, Rx Only, Distributed by: Alvogen, Inc., Morristown, NJ 07960. NDC 47781-304-03

Batch or Lot Expiration Information

Batch# Batch P0248AL0AT

Recall Number: D-0163-2024

Reason for Recall
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Initiated
01-26-2022
Reported
01-03-2024
Quantity
11 cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89450
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 HEALTHCARE
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.
Nationwide USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-29-2024
Product Description About Product Description
Full technical description of the product.
ALBUTEROL SULFATE IN 90MCG per actuation, 200 Metered Inhalations, Rx Only, 8.5 g Net Contents, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, India. NDC: 68180-963-01

Batch or Lot Expiration Information

Batch# Batch K100715

Affected Packages Involved in this Recall

68180-963-01 Albuterol Sulfate

Recall Number: D-0178-2024

Reason for Recall
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Initiated
01-26-2022
Reported
01-03-2024
Quantity
1 unit

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89450
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 HEALTHCARE
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.
Nationwide USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-29-2024
Product Description About Product Description
Full technical description of the product.
Doxycycline Capsules, USP 100 mg, 50 Capsules, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202 Unite States; Manufactured by: Lupin Limited, Nagpur - 441 108, INDIA. NDC 68180-652-08

Batch or Lot Expiration Information

Batch# Batch G104819

Affected Packages Involved in this Recall

68180-650-01 Doxycycline
68180-651-01 Doxycycline
68180-652-29 Doxycycline
68180-652-08 Doxycycline

Recall Number: D-0169-2024

Reason for Recall
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Initiated
01-26-2022
Reported
01-03-2024
Quantity
3 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89450
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 HEALTHCARE
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.
Nationwide USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-29-2024
Product Description About Product Description
Full technical description of the product.
Asmanex Twisthaler (mometasone furoate inhalation powder, 220 mcg per actuation), 120 Metered Doses, Rx only, Manufactured for: Organon LLC, a subsidiary of Organon & Co., Jersey City, NJ 07302; Manufactured by: MSD International GmbH (Singapore Branch) Singapore 638030, Singapore. NDC: 78206-114-01

Batch or Lot Expiration Information

Batch# Batch U027458

Affected Packages Involved in this Recall

78206-114-03 Asmanex
78206-114-04 Asmanex
78206-114-02 Asmanex
78206-114-01 Asmanex
78206-114-59 Asmanex
78206-115-59 Asmanex
78206-115-01 Asmanex

Recall Number: D-0175-2024

Reason for Recall
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Initiated
01-26-2022
Reported
01-03-2024
Quantity
1 unit

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89450
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 HEALTHCARE
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.
Nationwide USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-29-2024
Product Description About Product Description
Full technical description of the product.
Dicyclomine Hydrochloride Tablets, USP 20 mg, 100 Tablets, Rx only, Manufactured For: Teva Pharmaceuticals USA, Parsippany, NJ 07054. NDC: 0591-0795-01

Batch or Lot Expiration Information

Batch# Batch 3197790

Affected Packages Involved in this Recall

0591-0794-01 Dicyclomine Hydrochloride
0591-0794-10 Dicyclomine Hydrochloride
0591-0795-01 Dicyclomine Hydrochloride
0591-0795-10 Dicyclomine Hydrochloride

Recall Number: D-0199-2024

Reason for Recall
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Initiated
01-26-2022
Reported
01-03-2024
Quantity
2 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89450
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 HEALTHCARE
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.
Nationwide USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-29-2024
Product Description About Product Description
Full technical description of the product.
Triamterene and Hydrochlorothiazide Capsules, USP, 37.5 mg/25 mg, 100 capsules per bottle, Rx Only, Distributed by: Lannett Company, Inc, Philadelphia, PA 19136. NDC 0527-1632-01

Batch or Lot Expiration Information

Batch# Batch 21000279A, 21000280A

Recall Number: D-0181-2024

Reason for Recall
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Initiated
01-26-2022
Reported
01-03-2024
Quantity
1 unit

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89450
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 HEALTHCARE
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.
Nationwide USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-29-2024
Product Description About Product Description
Full technical description of the product.
FIRST LANSOPRAZOLE PT 3MG/ML, 300ML, Rx Only, Distributed By: CutisPharma, Inc., Woburn, MA 01801. NDC: 65628-080-10

Batch or Lot Expiration Information

Batch# Batch 21025A

Recall Number: D-0171-2024

Reason for Recall
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Initiated
01-26-2022
Reported
01-03-2024
Quantity
1 unit

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89450
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 HEALTHCARE
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.
Nationwide USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-29-2024
Product Description About Product Description
Full technical description of the product.
Bumetanide Tablets, USP, 2 mg, 100 Tablets per bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad 382213 India; Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807

Batch or Lot Expiration Information

Batch# Batch AM211171

Recall Number: D-0172-2024

Reason for Recall
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Initiated
01-26-2022
Reported
01-03-2024
Quantity
1 unit

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89450
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 HEALTHCARE
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.
Nationwide USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-29-2024
Product Description About Product Description
Full technical description of the product.
CHLORTHALIDONE Tablets, USP, 25MG, 1000 Tablets, Rx only, Manufactured by: Appco Pharma LLC, Piscataway, NJ 08854 USA; Manufactured For: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540 USA. NDC: 43598-719-10

Batch or Lot Expiration Information

Batch# Batch 2107329UM

Affected Packages Involved in this Recall

43598-719-01 Chlorthalidone
43598-719-10 Chlorthalidone
43598-720-01 Chlorthalidone
43598-720-10 Chlorthalidone

Recall Number: D-0198-2024

Reason for Recall
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Initiated
01-26-2022
Reported
01-03-2024
Quantity
1 unit

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89450
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 HEALTHCARE
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.
Nationwide USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-29-2024
Product Description About Product Description
Full technical description of the product.
Terconazole Vaginal Suppositories, 80 mg, 3 Suppositories with Vaginal Applicator, Rx only, Manufactured by: Cosette Pharmaceuticals, Inc., 111 Coolidge Street, South Plainfield, NJ 07080. NDC: 0713-0552-73

Batch or Lot Expiration Information

Batch# Batch 1014228A

Affected Packages Involved in this Recall

0713-0552-73 Terconazole

Recall Number: D-0192-2024

Reason for Recall
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Initiated
01-26-2022
Reported
01-03-2024
Quantity
2 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89450
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 HEALTHCARE
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.
Nationwide USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-29-2024
Product Description About Product Description
Full technical description of the product.
Nyamyc, 100,000 USP units per gram, 60 grams, Rx only, Topical Use Only, Manufactured by: Upsher-Smith Laboratories, Inc, Minneapolis, MN 55447.

Batch or Lot Expiration Information

Batch# Batch 400454

Recall Number: D-0174-2024

Reason for Recall
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Initiated
01-26-2022
Reported
01-03-2024
Quantity
1 unit

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89450
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 HEALTHCARE
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.
Nationwide USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-29-2024
Product Description About Product Description
Full technical description of the product.
Colgate Total SF Toothpaste, Net Wt 4.8 oz (136 g), Stannous Fluoride 0.454%, Clean Mint, Dist. by: COLGATE-PALMOLIVE CO., New York, NY 10022 USA

Batch or Lot Expiration Information

Batch# Batch 1293US561C

Recall Number: D-0161-2024

Reason for Recall
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Initiated
01-26-2022
Reported
01-03-2024
Quantity
2 cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89450
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 HEALTHCARE
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.
Nationwide USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-29-2024
Product Description About Product Description
Full technical description of the product.
Ipratropium Bromide and Albuterol Sulfate Inhalation Solution (0.5 mg/3 mg per 3 mL), 60 x 3 mL Sterile Unit-Dose Vials (2 pouches of 30 - 3 mL vials each), Manufactured By: The Ritedose Corporation, Columbia, SC 29203; Distributed By: Cipla USA Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-840-64

Batch or Lot Expiration Information

Batch# Batch 21C56

Affected Packages Involved in this Recall

69097-840-34 Ipratropium Bromide And Albuterol Sulfate
69097-840-53 Ipratropium Bromide And Albuterol Sulfate
69097-840-87 Ipratropium Bromide And Albuterol Sulfate
69097-840-64 Ipratropium Bromide And Albuterol Sulfate

Recall Number: D-0173-2024

Reason for Recall
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Initiated
01-26-2022
Reported
01-03-2024
Quantity
1 unit

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89450
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 HEALTHCARE
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.
Nationwide USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-29-2024
Product Description About Product Description
Full technical description of the product.
CITALOPRAM Tablets, USP, 20MG, 100 Tablets, Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA. NDC: 0378-6232-01

Batch or Lot Expiration Information

Batch# Batch 3131748

Affected Packages Involved in this Recall

0378-6231-01 Citalopram
0378-6231-05 Citalopram
0378-6232-01 Citalopram
0378-6232-05 Citalopram
0378-6233-01 Citalopram
0378-6233-05 Citalopram

Recall Number: D-0201-2024

Reason for Recall
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Initiated
01-26-2022
Reported
01-03-2024
Quantity
1 unit

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89450
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 HEALTHCARE
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.
Nationwide USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-29-2024
Product Description About Product Description
Full technical description of the product.
Warfarin Sodium Tablets, USP, 5 mg, 100 Tablets per bottle, Rx Only, Manufactured for: Teva Pharmaceuticals, Parsippany, NJ 07054. NDC: 0093-1721-01

Batch or Lot Expiration Information

Batch# Batch 2323041

Affected Packages Involved in this Recall

0093-1712-01 Warfarin Sodium
0093-1712-10 Warfarin Sodium
0093-1713-01 Warfarin Sodium
0093-1713-10 Warfarin Sodium
0093-1714-01 Warfarin Sodium
0093-1714-10 Warfarin Sodium
0093-1715-01 Warfarin Sodium
0093-1716-01 Warfarin Sodium
0093-1716-10 Warfarin Sodium
0093-1721-01 Warfarin Sodium
0093-1721-10 Warfarin Sodium
0093-1718-01 Warfarin Sodium
0093-1723-01 Warfarin Sodium
0093-1720-01 Warfarin Sodium

Recall Number: D-0195-2024

Reason for Recall
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Initiated
01-26-2022
Reported
01-03-2024
Quantity
2 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89450
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 HEALTHCARE
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.
Nationwide USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-29-2024
Product Description About Product Description
Full technical description of the product.
Ricola CherryHoney Herb Throat Drops (menthol, 1.8 mg), 10 Drops per roll, Manufacturer: Ricola Ltd., 4242 Laufen, Switzerland; Distributed by: Ricola USA Inc., 6 Campus Drive, 2nd Floor South, Parsippany, NJ 07054. NDC: 54305-507-10

Batch or Lot Expiration Information

Batch# Batch 2000058693

Affected Packages Involved in this Recall

54305-507-10 Natural Cherry Honey Herb Throat Drops

Recall Number: D-0190-2024

Reason for Recall
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Initiated
01-26-2022
Reported
01-03-2024
Quantity
1 unit

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89450
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 HEALTHCARE
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.
Nationwide USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-29-2024
Product Description About Product Description
Full technical description of the product.
Meloxicam Tablets, USP, 15 mg, 1000 Tablets per bottle, Rx Only, Manufactured by: Cipla Ltd., Kurkumbh, India; Manufactured for: Cipla USA, Inc., 9100 S. Dadeland Blvd., Suite 1500 Miami, FL 33156. NDC: 69097-159-15

Batch or Lot Expiration Information

Batch# Batch KA11489

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-0200-2024

Reason for Recall
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Initiated
01-26-2022
Reported
01-03-2024
Quantity
1 unit

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89450
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 HEALTHCARE
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.
Nationwide USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-29-2024
Product Description About Product Description
Full technical description of the product.
Warfarin Sodium Tablets, USP, 2.5 mg, 100 Tablets per bottle, Rx only, Manufactured For: Teva Pharmaceuticals, Parsippany, NJ 07054. NDC: 0093-1714-01

Batch or Lot Expiration Information

Batch# Batch 2169041

Affected Packages Involved in this Recall

0093-1712-01 Warfarin Sodium
0093-1712-10 Warfarin Sodium
0093-1713-01 Warfarin Sodium
0093-1713-10 Warfarin Sodium
0093-1714-01 Warfarin Sodium
0093-1714-10 Warfarin Sodium
0093-1715-01 Warfarin Sodium
0093-1716-01 Warfarin Sodium
0093-1716-10 Warfarin Sodium
0093-1721-01 Warfarin Sodium
0093-1721-10 Warfarin Sodium
0093-1718-01 Warfarin Sodium
0093-1723-01 Warfarin Sodium
0093-1720-01 Warfarin Sodium

Recall Number: D-0179-2024

Reason for Recall
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Initiated
01-26-2022
Reported
01-03-2024
Quantity
2 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89450
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 HEALTHCARE
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.
Nationwide USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-29-2024
Product Description About Product Description
Full technical description of the product.
Enoxaparin Sodium Injection, USP, 150MG/ML Single-Dose Syringes with Automatic Safety Device, For Subcutaneous Injection, Ten 1 mL Syringes per box, Rx Only, Sandoz Inc, Princeton, NJ 08540. NDC: 0781-3299-69

Batch or Lot Expiration Information

Batch# Batch SAH06821A

Affected Packages Involved in this Recall

0781-3238-01 Enoxaparin Sodium
0781-3238-63 Enoxaparin Sodium
0781-3246-02 Enoxaparin Sodium
0781-3246-64 Enoxaparin Sodium
0781-3256-03 Enoxaparin Sodium
0781-3256-66 Enoxaparin Sodium
0781-3262-04 Enoxaparin Sodium
0781-3262-68 Enoxaparin Sodium
0781-3268-05 Enoxaparin Sodium
0781-3268-69 Enoxaparin Sodium
0781-3298-04 Enoxaparin Sodium
0781-3298-68 Enoxaparin Sodium
0781-3299-05 Enoxaparin Sodium
0781-3299-69 Enoxaparin Sodium

Recall Number: D-0189-2024

Reason for Recall
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Initiated
01-26-2022
Reported
01-03-2024
Quantity
1 unit

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89450
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 HEALTHCARE
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.
Nationwide USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-29-2024
Product Description About Product Description
Full technical description of the product.
Lithium Carbonate Extended-Release Tablets, USP, 300 mg, 100 Tablets per bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505. NDC: 0378-1300-01

Batch or Lot Expiration Information

Batch# Batch 3138326

Recall Number: D-0170-2024

Reason for Recall
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Initiated
01-26-2022
Reported
01-03-2024
Quantity
2 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89450
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 HEALTHCARE
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.
Nationwide USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-29-2024
Product Description About Product Description
Full technical description of the product.
Low Dose ASPIRIN, 81 mg, 120 Enteric Coated Tablets, Distributed by: Rugby Lavoratories, 17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152. NDC: 0536-1234-41

Batch or Lot Expiration Information

Batch# Batch P126201

Affected Packages Involved in this Recall

0536-1234-41 Aspirin Low Dose

Recall Number: D-0177-2024

Reason for Recall
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Initiated
01-26-2022
Reported
01-03-2024
Quantity
1 unit

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89450
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 HEALTHCARE
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.
Nationwide USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-29-2024
Product Description About Product Description
Full technical description of the product.
Donepezil HCl Tablets, 5 mg, 90 Tablets, Rx only, Distributed by: Solco Healthcare U.S. LLC, Hurracao, Puerto Rico 00791. NDC: 43547-275-09

Batch or Lot Expiration Information

Batch# Batch 17605

Affected Packages Involved in this Recall

43547-275-03 Donepezil Hydrochloride
43547-275-09 Donepezil Hydrochloride
43547-275-11 Donepezil Hydrochloride
43547-276-03 Donepezil Hydrochloride
43547-276-09 Donepezil Hydrochloride
43547-276-11 Donepezil Hydrochloride

Recall Number: D-0164-2024

Reason for Recall
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Initiated
01-26-2022
Reported
01-03-2024
Quantity
1 unit

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89450
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 HEALTHCARE
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.
Nationwide USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-29-2024
Product Description About Product Description
Full technical description of the product.
ALLOPURINOL Tablets, USP 300 MG 500 count Tablets per bottle, Rx only, Manufactured By: Dr. Reddy's Laboratories LA LLC, Shreveport, LA 71106. NDC: 55111-730-05

Batch or Lot Expiration Information

Batch# Batch L100813

Affected Packages Involved in this Recall

55111-729-01 Allopurinol
55111-729-10 Allopurinol
55111-730-01 Allopurinol
55111-730-05 Allopurinol

Recall Number: D-0166-2024

Reason for Recall
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Initiated
01-26-2022
Reported
01-03-2024
Quantity
2 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89450
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 HEALTHCARE
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.
Nationwide USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-29-2024
Product Description About Product Description
Full technical description of the product.
AMOXICILLIN Tablets, USP, 875MG, 20 Tablets, Rx Only, Manufactured by Sandoz GmbH for Sandoz Inc., Princeton, NJ 08540. NDC: 0781-5060-20

Batch or Lot Expiration Information

Batch# Batch LJ9004

Affected Packages Involved in this Recall

0781-2020-31 Amoxicillin
0781-2020-76 Amoxicillin
0781-2020-01 Amoxicillin
0781-2020-05 Amoxicillin
0781-2613-31 Amoxicillin
0781-2613-76 Amoxicillin
0781-2613-01 Amoxicillin
0781-2613-05 Amoxicillin
0781-5060-20 Amoxicillin
0781-5060-01 Amoxicillin
0781-5061-20 Amoxicillin
0781-5061-01 Amoxicillin
0781-6039-58 Amoxicillin
0781-6039-46 Amoxicillin
0781-6039-55 Amoxicillin
0781-6156-52 Amoxicillin
0781-6156-57 Amoxicillin
0781-6156-46 Amoxicillin
0781-6041-58 Amoxicillin
0781-6041-46 Amoxicillin
0781-6041-55 Amoxicillin
0781-6157-52 Amoxicillin
0781-6157-57 Amoxicillin
0781-6157-46 Amoxicillin

Recall Number: D-0182-2024

Reason for Recall
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Initiated
01-26-2022
Reported
01-03-2024
Quantity
6 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89450
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 HEALTHCARE
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.
Nationwide USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-29-2024
Product Description About Product Description
Full technical description of the product.
Fluticasone Propionate Nasal Spray USP, 50MCG per spray, 16 g net fill weight, 120 Metered Sprays, For Intranasal Use Only, Rx Only, Manufactured for: Apotext Corp., Weston, FL 33326. NDC: 60505-0829-1

Batch or Lot Expiration Information

Batch# Batch TE9159, TE8156

Affected Packages Involved in this Recall

60505-0829-1 Fluticasone Propionate

Recall Number: D-0180-2024

Reason for Recall
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Initiated
01-26-2022
Reported
01-03-2024
Quantity
1 unit

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89450
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 HEALTHCARE
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.
Nationwide USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-29-2024
Product Description About Product Description
Full technical description of the product.
ESTRADIOL TABLETS USP, 0.5MG 100 Tablets, Tx Only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454. NDC: 0555-0899-02

Batch or Lot Expiration Information

Batch# Batch 100023687

Affected Packages Involved in this Recall

0555-0899-02 Estradiol
0555-0886-02 Estradiol
0555-0886-04 Estradiol
0555-0887-02 Estradiol
0555-0887-04 Estradiol

Recall Number: D-0184-2024

Reason for Recall
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Initiated
01-26-2022
Reported
01-03-2024
Quantity
2 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89450
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 HEALTHCARE
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.
Nationwide USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-29-2024
Product Description About Product Description
Full technical description of the product.
HydrALAZINE Hydrochloride Tablets, USP, 25 mg, 100 Tablets per bottle, Rx only, Distributed by: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816. NDC: 23155-002-01

Batch or Lot Expiration Information

Batch# Batch G210553, G210551

Affected Packages Involved in this Recall

23155-001-01 Hydralazine Hydrochloride
23155-001-10 Hydralazine Hydrochloride
23155-002-10 Hydralazine Hydrochloride
23155-002-01 Hydralazine Hydrochloride
23155-003-01 Hydralazine Hydrochloride
23155-003-10 Hydralazine Hydrochloride
23155-004-01 Hydralazine Hydrochloride
23155-004-10 Hydralazine Hydrochloride

Recall Number: D-0197-2024

Reason for Recall
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Initiated
01-26-2022
Reported
01-03-2024
Quantity
5 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89450
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 HEALTHCARE
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.
Nationwide USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-29-2024
Product Description About Product Description
Full technical description of the product.
SPIRIVA HANDIHALER (tiotropium bromide inhalation powder) 18 mcg/Capsule, 30 capsules, 3 blister cards, each card contains 10 capsules, Rx only, For oral inhalation only, Distributed by: Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT 06877 USA. NDC: 0597-0075-41

Batch or Lot Expiration Information

Batch# Batch 104440

Affected Packages Involved in this Recall

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

Recall Number: D-0165-2024

Reason for Recall
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Initiated
01-26-2022
Reported
01-03-2024
Quantity
3 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89450
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 HEALTHCARE
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.
Nationwide USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-29-2024
Product Description About Product Description
Full technical description of the product.
AMOXICILLIN for Oral Suspension USP, 400MG/5ML, 100ML (when reconstituted), Manufactured In Canada By: TEVA CANA LIMITED, Toronto, Canada M1B 2K9; Manufactured For: TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454. NDC: 0093-4161-73

Batch or Lot Expiration Information

Batch# Batch 35447184A

Affected Packages Involved in this Recall

0093-2263-01 Amoxicillin
0093-2264-01 Amoxicillin
0093-4160-76 Amoxicillin
0093-4160-78 Amoxicillin
0093-4160-73 Amoxicillin
0093-4155-79 Amoxicillin
0093-4155-73 Amoxicillin
0093-4155-80 Amoxicillin
0093-4161-76 Amoxicillin
0093-4161-78 Amoxicillin
0093-4161-73 Amoxicillin
0093-2267-01 Amoxicillin
0093-2268-01 Amoxicillin
0093-3107-01 Amoxicillin
0093-3107-05 Amoxicillin
0093-3109-53 Amoxicillin
0093-3109-05 Amoxicillin

Recall Number: D-0191-2024

Reason for Recall
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Initiated
01-26-2022
Reported
01-03-2024
Quantity
1 unit

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89450
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 HEALTHCARE
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.
Nationwide USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-29-2024
Product Description About Product Description
Full technical description of the product.
Metoprolol Succinate Extended-Release Tablets, USP, 50 mg, 1000 Tablets, Rx Only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454. NDC: 45963-676-96

Batch or Lot Expiration Information

Batch# Batch 2447J211

Affected Packages Involved in this Recall

45963-709-11 Metoprolol Succinate
45963-709-96 Metoprolol Succinate
45963-676-11 Metoprolol Succinate
45963-676-96 Metoprolol Succinate
45963-677-11 Metoprolol Succinate
45963-677-96 Metoprolol Succinate
45963-678-11 Metoprolol Succinate

Recall Number: D-0168-2024

Reason for Recall
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Initiated
01-26-2022
Reported
01-03-2024
Quantity
1 unit

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89450
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 HEALTHCARE
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.
Nationwide USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-29-2024
Product Description About Product Description
Full technical description of the product.
ARMOUR THYROID (thyroid tablets, USP), 2 GRAIN (120 mg), 100 Tablets, Rx Only, Distributed by: Allergan US, INc., Madison, NJ 07940. NDC: 0456-0461-01

Batch or Lot Expiration Information

Batch# Batch W05543

Affected Packages Involved in this Recall

0456-0457-01 Armour Thyroid
0456-1045-01 Armour Thyroid
0456-0458-01 Armour Thyroid
0456-0458-11 Armour Thyroid
0456-0458-63 Armour Thyroid
0456-0459-01 Armour Thyroid
0456-0459-11 Armour Thyroid
0456-0459-63 Armour Thyroid
0456-0460-01 Armour Thyroid
0456-0461-01 Armour Thyroid
0456-0461-11 Armour Thyroid
0456-0461-63 Armour Thyroid
0456-0462-01 Armour Thyroid
0456-0463-01 Armour Thyroid
0456-0464-01 Armour Thyroid

Recall Number: D-0185-2024

Reason for Recall
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Initiated
01-26-2022
Reported
01-03-2024
Quantity
1 unit

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89450
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 HEALTHCARE
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.
Nationwide USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-29-2024
Product Description About Product Description
Full technical description of the product.
Jardiance (empagliflozin tablets), 25 mg, 30 tablets (3 blister cards with 10 tablets each), Rx only, Distributed by: Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT 06877. NDC: 0597-0153-37

Batch or Lot Expiration Information

Batch# Batch D41919

Affected Packages Involved in this Recall

0597-0152-90 Jardiance
0597-0152-07 Jardiance
0597-0152-70 Jardiance
0597-0152-37 Jardiance
0597-0152-30 Jardiance
0597-0153-37 Jardiance
0597-0153-30 Jardiance
0597-0153-90 Jardiance
0597-0153-07 Jardiance
0597-0153-70 Jardiance

Recall Number: D-0186-2024

Reason for Recall
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Initiated
01-26-2022
Reported
01-03-2024
Quantity
1 unit

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89450
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 HEALTHCARE
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.
Nationwide USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-29-2024
Product Description About Product Description
Full technical description of the product.
Leader Nasal Decongestant PE (Phenylephrine HCl 10 mg), 18 Tablets per cartons, Distributed By Cardinal Health, Dublin, Ohio 43017. NDC: 70000-0126-1

Batch or Lot Expiration Information

Batch# Batch P125514

Recall Number: D-0167-2024

Reason for Recall
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Initiated
01-26-2022
Reported
01-03-2024
Quantity
2 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89450
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 HEALTHCARE
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.
Nationwide USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-29-2024
Product Description About Product Description
Full technical description of the product.
Aripiprazole Tablets, USP, 5 mg, 30 Tablets per bottle, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807. NDC: 65162-897-03

Batch or Lot Expiration Information

Batch# Batch AR202318

Affected Packages Involved in this Recall

65162-896-03 Aripiprazole
65162-896-09 Aripiprazole
65162-896-50 Aripiprazole
65162-896-11 Aripiprazole
65162-897-03 Aripiprazole
65162-897-09 Aripiprazole
65162-897-50 Aripiprazole
65162-897-11 Aripiprazole
65162-898-03 Aripiprazole
65162-898-09 Aripiprazole
65162-898-50 Aripiprazole
65162-898-11 Aripiprazole
65162-899-03 Aripiprazole
65162-899-09 Aripiprazole
65162-899-50 Aripiprazole
65162-899-11 Aripiprazole
65162-901-03 Aripiprazole
65162-901-09 Aripiprazole
65162-901-50 Aripiprazole
65162-901-11 Aripiprazole
65162-902-03 Aripiprazole
65162-902-09 Aripiprazole
65162-902-50 Aripiprazole
65162-902-11 Aripiprazole

Recall Number: D-0194-2024

Reason for Recall
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Initiated
01-26-2022
Reported
01-03-2024
Quantity
2 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89450
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 HEALTHCARE
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.
Nationwide USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-29-2024
Product Description About Product Description
Full technical description of the product.
Propranolol Hydrochloride Tablets, 20 mg, 100 Tablets per bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad 382213, India; Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807. NDC: 69238-2078-1

Batch or Lot Expiration Information

Batch# Batch 100023596

Affected Packages Involved in this Recall

69238-2077-1 Propranolol Hydrochloride
69238-2077-7 Propranolol Hydrochloride
69238-2078-1 Propranolol Hydrochloride
69238-2078-7 Propranolol Hydrochloride
69238-2079-1 Propranolol Hydrochloride
69238-2079-7 Propranolol Hydrochloride
69238-2080-1 Propranolol Hydrochloride
69238-2081-1 Propranolol Hydrochloride
69238-2081-5 Propranolol Hydrochloride

Recall Number: D-0162-2024

Reason for Recall
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Initiated
01-26-2022
Reported
01-03-2024
Quantity
2 cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89450
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 HEALTHCARE
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.
Nationwide USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-29-2024
Product Description About Product Description
Full technical description of the product.
ALBUTEROL SULFATE HFA Inhalation Aerosol, 90MCG per actuation, 200 Metered Inhalations, Net Wt. 18 g, Rx Only, Manufactured for: Prasco Laboratories, Mason, OH 45040 USA. NDC: 66993-019-68

Batch or Lot Expiration Information

Batch# Batch MY7E

Affected Packages Involved in this Recall

66993-019-68 Albuterol Sulfate Hfa

Recall Number: D-0188-2024

Reason for Recall
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Initiated
01-26-2022
Reported
01-03-2024
Quantity
2 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89450
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 HEALTHCARE
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.
Nationwide USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-29-2024
Product Description About Product Description
Full technical description of the product.
Lisinopril and Hydrochlorothiazide Tablets USP, 10mg/12.5mg, Rx only, 100 Tablets per bottles, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Nagpur-441 108, India. NDC: 68180-518-01

Batch or Lot Expiration Information

Batch# Batch Q101699, Q101981

Affected Packages Involved in this Recall

68180-518-02 Lisinopril And Hydrochlorothiazide
68180-518-01 Lisinopril And Hydrochlorothiazide
68180-518-30 Lisinopril And Hydrochlorothiazide
68180-519-30 Lisinopril And Hydrochlorothiazide
68180-519-01 Lisinopril And Hydrochlorothiazide
68180-519-02 Lisinopril And Hydrochlorothiazide
68180-520-02 Lisinopril And Hydrochlorothiazide
68180-520-30 Lisinopril And Hydrochlorothiazide
68180-520-01 Lisinopril And Hydrochlorothiazide

Recall Number: D-0193-2024

Reason for Recall
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Initiated
01-26-2022
Reported
01-03-2024
Quantity
1 unit

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89450
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 HEALTHCARE
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.
Nationwide USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-29-2024
Product Description About Product Description
Full technical description of the product.
PredniSONE Tablets, USP, 20 mg, 100 Tablets per bottle, Rx Only, Manufactured by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801. NDC: 59746-175-06

Batch or Lot Expiration Information

Batch# Batch 21P0659

Recall Number: D-0202-2024

Reason for Recall
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Initiated
01-26-2022
Reported
01-03-2024
Quantity
1 unit

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89450
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 HEALTHCARE
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.
Nationwide USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-29-2024
Product Description About Product Description
Full technical description of the product.
Inhub Wixela (fluticasone propionate and salmeterol inhalation powder, USP) 500/50MCG, 60 Doses of Inhalation Powder, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505. NDC: 0378-9320-32

Batch or Lot Expiration Information

Batch# Batch 62002532

Affected Packages Involved in this Recall

0378-9320-32 Wixela Inhub
0378-9321-32 Wixela Inhub
0378-9322-32 Wixela Inhub