Multi-event July 2021 FDA Recall Metoclopramide by Teva Pharmaceuticals Usa

This Multi-event Class II drug recall was voluntarily initiated by Teva Pharmaceuticals Usa on July 29, 2021 for the product Metoclopramide. The FDA reported the reason for recall as lack of assurance of sterility. The product was distributed Nationwide and the recall is currently terminated.

Reported Recall Events

D-0732-2021 TERMINATED D-0734-2021 TERMINATED D-0739-2021 TERMINATED D-0736-2021 TERMINATED D-0743-2021 TERMINATED D-0745-2021 TERMINATED D-0735-2021 TERMINATED D-0730-2021 TERMINATED D-0747-2021 TERMINATED D-0744-2021 TERMINATED D-0746-2021 TERMINATED D-0733-2021 TERMINATED D-0740-2021 TERMINATED D-0738-2021 TERMINATED D-0737-2021 TERMINATED D-0748-2021 TERMINATED D-0742-2021 TERMINATED D-0731-2021 TERMINATED D-0741-2021 TERMINATED

Recall Number: D-0732-2021

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-29-2021
Reported
08-25-2021
Quantity
16,226 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
88442
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.
Teva Pharmaceuticals USA
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.
Product was distributed Nationwide, including Puerto Rico.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-04-2024
Product Description About Product Description
Full technical description of the product.
Haloperidol Decanoate Injection 100 mg/mL, packaged in a) 1 mL single-dose vials (NDC 0703-7131-01), b) 5 mL multi-dose vials (NDC 0703-7133-01), Rx only, Teva Pharmaceuticals USA, Inc. North Wales, PA 19454.

Batch or Lot Expiration Information

Lot# : a) 31327056B, exp. date 03/2022; 31328547B, exp. date 01/2023; b) 31327066B, exp. date 03/2022

Recall Number: D-0734-2021

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-29-2021
Reported
08-25-2021
Quantity
2,091 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
88442
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.
Teva Pharmaceuticals USA
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.
Product was distributed Nationwide, including Puerto Rico.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-04-2024
Product Description About Product Description
Full technical description of the product.
Idarubicin Hydrochloride Injection 20 mg/20 mL, 20 mL single-dose vial, Rx only, Teva Pharmaceuticals USA, Inc. North Wales, PA 19454, NDC 0703-4156-11

Batch or Lot Expiration Information

Lot# : 31328668B, exp. date 04/2023

Recall Number: D-0739-2021

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-29-2021
Reported
08-25-2021
Quantity
34,100 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
88442
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.
Teva Pharmaceuticals USA
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.
Product was distributed Nationwide, including Puerto Rico.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-04-2024
Product Description About Product Description
Full technical description of the product.
Norepinephrine Bitartrate Injection, USP 4 mg/4 mL, 4 mL single dose vials, packaged in 10 vial cartons (NDC 0703-1153-03) Rx only, Teva Pharmaceuticals USA Inc. North Wales, PA 19454, vial NDC 0703-1153-01

Batch or Lot Expiration Information

Lot# : 31329045B, exp. date 07/2021; 31329077B, exp. date 08/2021; 31329312B, exp. date 09/2021

Recall Number: D-0736-2021

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-29-2021
Reported
08-25-2021
Quantity
16,644 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
88442
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.
Teva Pharmaceuticals USA
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.
Product was distributed Nationwide, including Puerto Rico.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-04-2024
Product Description About Product Description
Full technical description of the product.
Octreotide Acetate Injection 1000 mcg/5mL, 5 mL multi-dose vial, Rx only, Teva Pharmaceuticals USA. Inc. North Wales, PA 19454, NDC 0703-3333-01

Batch or Lot Expiration Information

Lot# : 31329150B, exp. date 06/2022

Recall Number: D-0743-2021

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-29-2021
Reported
08-25-2021
Quantity
50,713 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
88442
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.
Teva Pharmaceuticals USA
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.
Product was distributed Nationwide, including Puerto Rico.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-04-2024
Product Description About Product Description
Full technical description of the product.
Methylprednisolone Acetate Injectable Suspension USP, 80 mg/mL, packaged in a) 1 mL Single-Dose vials (0703-0051-01), and b) 5mL Multi Dose Vials (NDC 0703-0063-01), Rx only, TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454.

Batch or Lot Expiration Information

Lot# : a) 31329363B, exp. date 01/2022; 31329484B, exp. date 03/2022 b) 31328367B, 31328431B, exp. date 07/2021; 31329014B, exp. date 11/2021

Recall Number: D-0745-2021

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-29-2021
Reported
08-25-2021
Quantity
6,184 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
88442
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.
Teva Pharmaceuticals USA
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.
Product was distributed Nationwide, including Puerto Rico.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-04-2024
Product Description About Product Description
Full technical description of the product.
Octreotide Acetate Injection 50 mcg/mL, 1 mL single-dose vial, Rx only, Teva Pharmaceuticals USA. Inc. North Wales, PA 19454, NDC 0703-3301-01

Batch or Lot Expiration Information

Lot# : 31329169B, 31329231B, exp. Date 06/2022

Recall Number: D-0735-2021

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-29-2021
Reported
08-25-2021
Quantity
62,358 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
88442
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.
Teva Pharmaceuticals USA
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.
Product was distributed Nationwide, including Puerto Rico.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-04-2024
Product Description About Product Description
Full technical description of the product.
Vecuronium Bromide for Injection 10 mg, 10mL vial, Rx only, Teva Pharmaceuticals USA, North Wales, PA 19454, NDC 0703-2914-01

Batch or Lot Expiration Information

Lot# : 31325960B, exp. date12/2021; 31326111B, exp. date 01/2022; 31326875B, exp. date 03/2022; 31326915B, exp. date 03/2022; 31326916B, 31326917B, exp. date 04/2022; 31329079B, exp. date 04/2023; 31329085B, exp. date 05/2023

Recall Number: D-0730-2021

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-29-2021
Reported
08-25-2021
Quantity
1,351 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
88442
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.
Teva Pharmaceuticals USA
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.
Product was distributed Nationwide, including Puerto Rico.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-04-2024
Product Description About Product Description
Full technical description of the product.
DAUNOrubicin Hydrochloride Injection 20 mg/4mL, 4mL Single Dose vials, 10 in 1 carton, Rx only, Teva Parenteral Medicines, Inc. Irvine, CA 92618 Vial NDC# 0703-5233-11, Carton NDC # 0703-5233-13

Batch or Lot Expiration Information

Lot# : 31329250B, exp. date 08/2022

Recall Number: D-0747-2021

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-29-2021
Reported
08-25-2021
Quantity
42,046 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
88442
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.
Teva Pharmaceuticals USA
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.
Product was distributed Nationwide, including Puerto Rico.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-04-2024
Product Description About Product Description
Full technical description of the product.
Leucovorin Calcium for Injection, USP 350 mg/vial, 17.5 mL single-use vials, Rx only, Manufactured by: Teva Pharmaceuticals USA, Inc. North Wales, PA 19454, NDC 0703-5145-91

Batch or Lot Expiration Information

Lot# : 313282585B, exp. date 11/2022

Recall Number: D-0744-2021

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-29-2021
Reported
08-25-2021
Quantity
3,067 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
88442
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.
Teva Pharmaceuticals USA
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.
Product was distributed Nationwide, including Puerto Rico.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-04-2024
Product Description About Product Description
Full technical description of the product.
Octreotide Acetate Injection 100 mcg/mL, 1 mL single-dose vial, Rx only, Teva Pharmaceuticals USA. Inc. North Wales, PA 19454, NDC 0703-3311-01

Batch or Lot Expiration Information

Lot# : 31327466B, exp. date 08/2021

Recall Number: D-0746-2021

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-29-2021
Reported
08-25-2021
Quantity
476,275 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
88442
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.
Teva Pharmaceuticals USA
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.
Product was distributed Nationwide, including Puerto Rico.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-04-2024
Product Description About Product Description
Full technical description of the product.
Leucovorin Calcium for Injection, USP 100 mg/vial, 10 mL single-use vials, Rx only, Teva Parenteral Medicines, Inc. Irvine, CA 92618, NDC 0703-5140-01

Batch or Lot Expiration Information

Lot# : 31325596B, exp. date 08/2021; 31328129B, exp. date 11/2022; 31328356B, exp. date 01/2023; 31329297B, exp. date 06/2023; 31329569B, 31329821B, exp. date 08/2023

Recall Number: D-0733-2021

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-29-2021
Reported
08-25-2021
Quantity
4,712 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
88442
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.
Teva Pharmaceuticals USA
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.
Product was distributed Nationwide, including Puerto Rico.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-04-2024
Product Description About Product Description
Full technical description of the product.
Amikacin Sulfate Injection USP 1 gram/4mL (250mg/ML), 4 mL single-dose vials, Rx only, Teva Pharmaceuticals USA Inc. North Wales, PA 19454, NDC 0703-9040-01

Batch or Lot Expiration Information

Lot# : 31329243B, exp. date 05/2022

Recall Number: D-0740-2021

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-29-2021
Reported
08-25-2021
Quantity
4,249 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
88442
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.
Teva Pharmaceuticals USA
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.
Product was distributed Nationwide, including Puerto Rico.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-04-2024
Product Description About Product Description
Full technical description of the product.
Adenosine Injection, USP, 60mg/20mL (3 mg/mL), 20 mL single-dose vial, Rx only, Manufactured by: Teva Pharmaceuticals USA Inc. Parsippany, NJ 07054, NDC 0703-8776-01

Batch or Lot Expiration Information

Lot# : 100022400, exp. date 04/2023

Recall Number: D-0738-2021

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-29-2021
Reported
08-25-2021
Quantity
12,698 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
88442
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.
Teva Pharmaceuticals USA
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.
Product was distributed Nationwide, including Puerto Rico.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-04-2024
Product Description About Product Description
Full technical description of the product.
Epoprostenol Sodium for Injection, 1.5 mg/vial, 10 mL vials, Rx only, Teva Pharmaceuticals USA, Inc. North Wales, PA 19454, NDC 0703-1995-01

Batch or Lot Expiration Information

Lot# : 31329113B, exp. date 05/2022

Recall Number: D-0737-2021

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-29-2021
Reported
08-25-2021
Quantity
434,229 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
88442
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.
Teva Pharmaceuticals USA
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.
Product was distributed Nationwide, including Puerto Rico.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-04-2024
Product Description About Product Description
Full technical description of the product.
Leucovorin Calcium for Injection, USP 350 mg/vial, 17.5 mL single-use vials, Rx only, Teva Parenteral Medicines, Inc. Irvine, CA 92618, NDC 0703-5145-01

Batch or Lot Expiration Information

Lot# : 31325852B, 31325985B, exp. date 10/2021; 31326349B, exp. date 01/2022; 31326873B, exp. date 03/2022; 31326995B, exp. date 05/2022 31327158B, exp. date 06/2022; 31328946B, 31329180B, exp. date 05/2023.

Recall Number: D-0748-2021

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-29-2021
Reported
08-25-2021
Quantity
20,800 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
88442
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.
Teva Pharmaceuticals USA
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.
Product was distributed Nationwide, including Puerto Rico.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-04-2024
Product Description About Product Description
Full technical description of the product.
Adenosine Injection, USP, 60mg/20 mL (3 mg/mL), 20 mL single-dose vial, Rx only, Mfd in the USA for: NorthStar Rx LLC Memphis, TN 38141, NDC 16714-180-01

Batch or Lot Expiration Information

Lot# : 100022401, exp. date 04/2023

Recall Number: D-0742-2021

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-29-2021
Reported
08-25-2021
Quantity
2,199 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
88442
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.
Teva Pharmaceuticals USA
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.
Product was distributed Nationwide, including Puerto Rico.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-04-2024
Product Description About Product Description
Full technical description of the product.
Alprostadil Injection USP, 500 mg/mL, 1 mL single dose, vials, 5 mL single use vial per carton (NDC 0703-1501-02), Rx only, Teva Pharmaceuticals USA, Inc. Parsippany, NJ 07054, Vial NDC 0703-1501-01

Batch or Lot Expiration Information

Lot# : 31329295B, exp date. 01/2022

Recall Number: D-0731-2021

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-29-2021
Reported
08-25-2021
Quantity
193,845 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
88442
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.
Teva Pharmaceuticals USA
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.
Product was distributed Nationwide, including Puerto Rico.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-04-2024
Product Description About Product Description
Full technical description of the product.
Methylprednisolone Acetate Injectable Suspension USP, 40 mg/mL, packaged in a) 1 mL Single-Dose vials (0703-0031-01), and b) 5mL Multi Dose Vials (NDC 0703-0043-01), and c) 10 mL Multi-Dose Vials (NDC 0703-0045-01), Rx only, TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454.

Batch or Lot Expiration Information

Lot# : a) 31328455B, exp. date 09/2021; 31329340B, exp. date 12/2021; 31329439B, exp. date 01/2022; 31328347B, exp. date 07/2021 b) 31328321B, exp. date 07/2021; c) 31328368B, 31328394B, exp. date 07/2021; 31328699B, exp. date 09/2021; 31328834B, exp. date 10/2021; 31329286B, exp. date 12/2021

Recall Number: D-0741-2021

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-29-2021
Reported
08-25-2021
Quantity
25,653 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
88442
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.
Teva Pharmaceuticals USA
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.
Product was distributed Nationwide, including Puerto Rico.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-04-2024
Product Description About Product Description
Full technical description of the product.
Metoclopramide Injection USP, 10 mg/2mL (5 mg/mL) 2 mL single-use vial, Rx only, Teva Parenteral Medicines, Inc. Irvine, CA 92618, NDC 0703-4502-01

Batch or Lot Expiration Information

Lot# : 31326043B, exp. date 10/2021; 31326138B, exp. date 11/2021 31329399B, 31329539B, exp. date 08/2023; 31329599B, exp. date 09/2023

Affected Packages Involved in this Recall

0703-4502-01 Metoclopramide
0703-4502-04 Metoclopramide