Medications & Supplements/Prescription Drugs

Teva Pharmaceuticals USA: Various Injectable Medications Recalled for Lack of Assurance of Sterility

Agency Publication Date: August 16, 2021

Summary

Teva Pharmaceuticals USA is recalling approximately 1,409,440 vials of various injectable medications, including Leucovorin Calcium, Methylprednisolone Acetate, and Adenosine, due to a lack of assurance of sterility. These prescription drugs were distributed nationwide and in Puerto Rico. Using a non-sterile injectable drug can lead to serious, life-threatening infections, particularly in hospitalized or immunocompromised patients. No specific reports of illness or injury have been confirmed in this data.

Risk

The medications may not be completely sterile, which could introduce bacteria or other pathogens directly into a patient's bloodstream or tissue during injection. This poses a significant risk of systemic infection, sepsis, or localized abscesses that may require intensive medical treatment.

What You Should Do

Identify if you have any of the affected medications by checking the product name, NDC number, and lot numbers on the vial or carton. Affected products include Leucovorin Calcium (NDC 0703-5140-01, 0703-5145-91, 0703-5145-01), Adenosine (NDC 16714-180-01, 0703-8776-01), Octreotide Acetate (NDC 0703-3311-01, 0703-3301-01, 0703-3333-01), DAUNOrubicin (NDC 0703-5233-11), Methylprednisolone Acetate (NDC 0703-0031-01, 0703-0043-01, 0703-0045-01, 0703-0051-01, 0703-0063-01), Haloperidol Decanoate (NDC 0703-7131-01, 0703-7133-01), Amikacin Sulfate (NDC 0703-9040-01), Idarubicin (NDC 0703-4156-11), Vecuronium Bromide (NDC 0703-2914-01), Epoprostenol Sodium (NDC 0703-1995-01), Norepinephrine Bitartrate (NDC 0703-1153-01), Metoclopramide (NDC 0703-4502-01), and Alprostadil (NDC 0703-1501-01).
Check specific lot numbers and expiration dates, such as Leucovorin lot 31325596B (Exp 08/2021) or Vecuronium Bromide lots 31325960B through 31329085B with expiration dates ranging from 12/2021 to 05/2023.
If you are a patient using any of these medications, contact your healthcare provider or pharmacist immediately to determine if your supply is affected and to obtain a safe replacement.
Return any unused or affected medication vials to your pharmacy or place of purchase for a full refund.
Healthcare facilities and distributors should immediately stop using these products and contact Teva Pharmaceuticals USA at 400 Interpace Pkwy, Parsippany, New Jersey for return instructions.
For further questions or to report a problem, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Full refund and product return

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Leucovorin Calcium for Injection, USP 100 mg/vial, 10 mL single-use vials

Model:

NDC 0703-5140-01

Lot Numbers:

31325596B (Exp 08/2021)

31328129B (Exp 11/2022)

31328356B (Exp 01/2023)

31329297B (Exp 06/2023)

31329569B (Exp 08/2023)

31329821B (Exp 08/2023)

Date Ranges: 08/2021, 11/2022, 01/2023, 06/2023, 08/2023

Product: Leucovorin Calcium for Injection, USP 350 mg/vial, 17.5 mL single-use vials (North Wales)

Model:

NDC 0703-5145-91

Lot Numbers:

313282585B (Exp 11/2022)

Date Ranges: 11/2022

Product: Adenosine Injection, USP, 60mg/20 mL (3 mg/mL), 20 mL single-dose vial (NorthStar)

Model:

NDC 16714-180-01

Lot Numbers:

100022401 (Exp 04/2023)

Date Ranges: 04/2023

Product: Octreotide Acetate Injection 100 mcg/mL, 1 mL single-dose vial

Model:

NDC 0703-3311-01

Lot Numbers:

31327466B (Exp 08/2021)

Date Ranges: 08/2021

Product: Octreotide Acetate Injection 50 mcg/mL, 1 mL single-dose vial

Model:

NDC 0703-3301-01

Lot Numbers:

31329169B (Exp 06/2022)

31329231B (Exp 06/2022)

Date Ranges: 06/2022

Product: DAUNOrubicin Hydrochloride Injection 20 mg/4mL, 4mL Single Dose vials

Model:

NDC 0703-5233-11

NDC 0703-5233-13

Lot Numbers:

31329250B (Exp 08/2022)

Date Ranges: 08/2022

Product: Methylprednisolone Acetate Injectable Suspension USP, 40 mg/mL (1mL, 5mL, 10mL)

Model:

NDC 0703-0031-01

NDC 0703-0043-01

NDC 0703-0045-01

Lot Numbers:

31328455B (Exp 09/2021)

31329340B (Exp 12/2021)

31329439B (Exp 01/2022)

31328347B (Exp 07/2021)

31328321B (Exp 07/2021)

31328368B (Exp 07/2021)

31328394B (Exp 07/2021)

31328699B (Exp 09/2021)

31328834B (Exp 10/2021)

31329286B (Exp 12/2021)

Date Ranges: 07/2021, 09/2021, 10/2021, 12/2021, 01/2022

Product: Haloperidol Decanoate Injection 100 mg/mL (1mL, 5mL)

Model:

NDC 0703-7131-01

NDC 0703-7133-01

Lot Numbers:

31327056B (Exp 03/2022)

31328547B (Exp 01/2023)

31327066B (Exp 03/2022)

Date Ranges: 03/2022, 01/2023

Product: Amikacin Sulfate Injection USP 1 gram/4mL, 4 mL single-dose vials

Model:

NDC 0703-9040-01

Lot Numbers:

31329243B (Exp 05/2022)

Date Ranges: 05/2022

Product: Idarubicin Hydrochloride Injection 20 mg/20 mL, 20 mL single-dose vial

Model:

NDC 0703-4156-11

Lot Numbers:

31328668B (Exp 04/2023)

Date Ranges: 04/2023

Product: Vecuronium Bromide for Injection 10 mg, 10mL vial

Model:

NDC 0703-2914-01

Lot Numbers:

31325960B (Exp 12/2021)

31326111B (Exp 01/2022)

31326875B (Exp 03/2022)

31326915B (Exp 03/2022)

31326916B (Exp 04/2022)

31326917B (Exp 04/2022)

31329079B (Exp 04/2023)

31329085B (Exp 05/2023)

Date Ranges: 12/2021, 01/2022, 03/2022, 04/2022, 04/2023, 05/2023

Product: Octreotide Acetate Injection 1000 mcg/5mL, 5 mL multi-dose vial

Model:

NDC 0703-3333-01

Lot Numbers:

31329150B (Exp 06/2022)

Date Ranges: 06/2022

Product: Leucovorin Calcium for Injection, USP 350 mg/vial, 17.5 mL single-use vials (Irvine)

Model:

NDC 0703-5145-01

Lot Numbers:

31325852B (Exp 10/2021)

31325985B (Exp 10/2021)

31326349B (Exp 01/2022)

31326873B (Exp 03/2022)

31326995B (Exp 05/2022)

31327158B (Exp 06/2022)

31328946B (Exp 05/2023)

31329180B (Exp 05/2023)

Date Ranges: 10/2021, 01/2022, 03/2022, 05/2022, 06/2022, 05/2023

Product: Epoprostenol Sodium for Injection, 1.5 mg/vial, 10 mL vials

Model:

NDC 0703-1995-01

Lot Numbers:

31329113B (Exp 05/2022)

Date Ranges: 05/2022

Product: Norepinephrine Bitartrate Injection, USP 4 mg/4 mL, 4 mL single dose vials

Model:

NDC 0703-1153-03

NDC 0703-1153-01

Lot Numbers:

31329045B (Exp 07/2021)

31329077B (Exp 08/2021)

31329312B (Exp 09/2021)

Date Ranges: 07/2021, 08/2021, 09/2021

Product: Adenosine Injection, USP, 60mg/20mL (3 mg/mL), 20 mL single-dose vial (Teva)

Model:

NDC 0703-8776-01

Lot Numbers:

100022400 (Exp 04/2023)

Date Ranges: 04/2023

Product: Metoclopramide Injection USP, 10 mg/2mL (5 mg/mL) 2 mL single-use vial

Model:

NDC 0703-4502-01

Lot Numbers:

31326043B (Exp 10/2021)

31326138B (Exp 11/2021)

31329399B (Exp 08/2023)

31329539B (Exp 08/2023)

31329599B (Exp 09/2023)

Date Ranges: 10/2021, 11/2021, 08/2023, 09/2023

Product: Alprostadil Injection USP, 500 mg/mL, 1 mL single dose vials

Model:

NDC 0703-1501-02

NDC 0703-1501-01

Lot Numbers:

31329295B (Exp 01/2022)

Date Ranges: 01/2022

Product: Methylprednisolone Acetate Injectable Suspension USP, 80 mg/mL (1mL, 5mL)

Model:

NDC 0703-0051-01

NDC 0703-0063-01

Lot Numbers:

31329363B (Exp 01/2022)

31329484B (Exp 03/2022)

31328367B (Exp 07/2021)

31328431B (Exp 07/2021)

31329014B (Exp 11/2021)

Date Ranges: 07/2021, 11/2021, 01/2022, 03/2022

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 88442

Status: Resolved

Manufacturer: Teva Pharmaceuticals USA

Sold By: NorthStar Rx LLC; Teva Parenteral Medicines, Inc.; Teva Pharmaceuticals USA, Inc.

Manufactured In: United States

Units Affected: 19 products (1,351 vials; 193,845 vials; 16,226 vials; 4,712 vials; 2,091 vials; 62,358 vials; 16,644 vials; 434,229 vials; 12,698 vials; 34,100 vials; 4,249 vials; 25,653 vials; 2,199 vials; 50,713 vials; 3,067 vials; 6,184 vials; 476,275 vials; 42,046 vials; 20,800 vials)

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Identify if you have any of the affected medications by checking the product name, NDC number, and lot numbers on the vial or carton. Affected products include Leucovorin Calcium (NDC 0703-5140-01, 0703-5145-91, 0703-5145-01), Adenosine (NDC 16714-180-01, 0703-8776-01), Octreotide Acetate (NDC 0703-3311-01, 0703-3301-01, 0703-3333-01), DAUNOrubicin (NDC 0703-5233-11), Methylprednisolone Acetate (NDC 0703-0031-01, 0703-0043-01, 0703-0045-01, 0703-0051-01, 0703-0063-01), Haloperidol Decanoate (NDC 0703-7131-01, 0703-7133-01), Amikacin Sulfate (NDC 0703-9040-01), Idarubicin (NDC 0703-4156-11), Vecuronium Bromide (NDC 0703-2914-01), Epoprostenol Sodium (NDC 0703-1995-01), Norepinephrine Bitartrate (NDC 0703-1153-01), Metoclopramide (NDC 0703-4502-01), and Alprostadil (NDC 0703-1501-01).

Check specific lot numbers and expiration dates, such as Leucovorin lot 31325596B (Exp 08/2021) or Vecuronium Bromide lots 31325960B through 31329085B with expiration dates ranging from 12/2021 to 05/2023.

If you are a patient using any of these medications, contact your healthcare provider or pharmacist immediately to determine if your supply is affected and to obtain a safe replacement.

Return any unused or affected medication vials to your pharmacy or place of purchase for a full refund.

Healthcare facilities and distributors should immediately stop using these products and contact Teva Pharmaceuticals USA at 400 Interpace Pkwy, Parsippany, New Jersey for return instructions.

For further questions or to report a problem, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Affected Products

Product: Leucovorin Calcium for Injection, USP 100 mg/vial, 10 mL single-use vials

Model:

NDC 0703-5140-01

Lot Numbers:

31325596B (Exp 08/2021)

31328129B (Exp 11/2022)

31328356B (Exp 01/2023)

31329297B (Exp 06/2023)

31329569B (Exp 08/2023)

31329821B (Exp 08/2023)

Date Ranges: 08/2021, 11/2022, 01/2023, 06/2023, 08/2023

Product: Leucovorin Calcium for Injection, USP 350 mg/vial, 17.5 mL single-use vials (North Wales)

Model:

NDC 0703-5145-91

Lot Numbers:

313282585B (Exp 11/2022)

Date Ranges: 11/2022

Product: Adenosine Injection, USP, 60mg/20 mL (3 mg/mL), 20 mL single-dose vial (NorthStar)

Model:

NDC 16714-180-01

Lot Numbers:

100022401 (Exp 04/2023)

Date Ranges: 04/2023

Product: Octreotide Acetate Injection 100 mcg/mL, 1 mL single-dose vial

Model:

NDC 0703-3311-01

Lot Numbers:

31327466B (Exp 08/2021)

Date Ranges: 08/2021

Product: Octreotide Acetate Injection 50 mcg/mL, 1 mL single-dose vial

Model:

NDC 0703-3301-01

Lot Numbers:

31329169B (Exp 06/2022)

31329231B (Exp 06/2022)

Date Ranges: 06/2022

Product: DAUNOrubicin Hydrochloride Injection 20 mg/4mL, 4mL Single Dose vials

Model:

NDC 0703-5233-11

NDC 0703-5233-13

Lot Numbers:

31329250B (Exp 08/2022)

Date Ranges: 08/2022

Product: Methylprednisolone Acetate Injectable Suspension USP, 40 mg/mL (1mL, 5mL, 10mL)

Model:

NDC 0703-0031-01

NDC 0703-0043-01

NDC 0703-0045-01

Lot Numbers:

31328455B (Exp 09/2021)

31329340B (Exp 12/2021)

31329439B (Exp 01/2022)

31328347B (Exp 07/2021)

31328321B (Exp 07/2021)

31328368B (Exp 07/2021)

31328394B (Exp 07/2021)

31328699B (Exp 09/2021)

31328834B (Exp 10/2021)

31329286B (Exp 12/2021)

Date Ranges: 07/2021, 09/2021, 10/2021, 12/2021, 01/2022

Product: Haloperidol Decanoate Injection 100 mg/mL (1mL, 5mL)

Model:

NDC 0703-7131-01

NDC 0703-7133-01

Lot Numbers:

31327056B (Exp 03/2022)

31328547B (Exp 01/2023)

31327066B (Exp 03/2022)

Date Ranges: 03/2022, 01/2023

Product: Amikacin Sulfate Injection USP 1 gram/4mL, 4 mL single-dose vials

Model:

NDC 0703-9040-01

Lot Numbers:

31329243B (Exp 05/2022)

Date Ranges: 05/2022

Product: Idarubicin Hydrochloride Injection 20 mg/20 mL, 20 mL single-dose vial

Model:

NDC 0703-4156-11

Lot Numbers:

31328668B (Exp 04/2023)

Date Ranges: 04/2023

Product: Vecuronium Bromide for Injection 10 mg, 10mL vial

Model:

NDC 0703-2914-01

Lot Numbers:

31325960B (Exp 12/2021)

31326111B (Exp 01/2022)

31326875B (Exp 03/2022)

31326915B (Exp 03/2022)

31326916B (Exp 04/2022)

31326917B (Exp 04/2022)

31329079B (Exp 04/2023)

31329085B (Exp 05/2023)

Date Ranges: 12/2021, 01/2022, 03/2022, 04/2022, 04/2023, 05/2023

Product: Octreotide Acetate Injection 1000 mcg/5mL, 5 mL multi-dose vial

Model:

NDC 0703-3333-01

Lot Numbers:

31329150B (Exp 06/2022)

Date Ranges: 06/2022

Product: Leucovorin Calcium for Injection, USP 350 mg/vial, 17.5 mL single-use vials (Irvine)

Model:

NDC 0703-5145-01

Lot Numbers:

31325852B (Exp 10/2021)

31325985B (Exp 10/2021)

31326349B (Exp 01/2022)

31326873B (Exp 03/2022)

31326995B (Exp 05/2022)

31327158B (Exp 06/2022)

31328946B (Exp 05/2023)

31329180B (Exp 05/2023)

Date Ranges: 10/2021, 01/2022, 03/2022, 05/2022, 06/2022, 05/2023

Product: Epoprostenol Sodium for Injection, 1.5 mg/vial, 10 mL vials

Model:

NDC 0703-1995-01

Lot Numbers:

31329113B (Exp 05/2022)

Date Ranges: 05/2022

Product: Norepinephrine Bitartrate Injection, USP 4 mg/4 mL, 4 mL single dose vials

Model:

NDC 0703-1153-03

NDC 0703-1153-01

Lot Numbers:

31329045B (Exp 07/2021)

31329077B (Exp 08/2021)

31329312B (Exp 09/2021)

Date Ranges: 07/2021, 08/2021, 09/2021

Product: Adenosine Injection, USP, 60mg/20mL (3 mg/mL), 20 mL single-dose vial (Teva)

Model:

NDC 0703-8776-01

Lot Numbers:

100022400 (Exp 04/2023)

Date Ranges: 04/2023

Product: Metoclopramide Injection USP, 10 mg/2mL (5 mg/mL) 2 mL single-use vial

Model:

NDC 0703-4502-01

Lot Numbers:

31326043B (Exp 10/2021)

31326138B (Exp 11/2021)

31329399B (Exp 08/2023)

31329539B (Exp 08/2023)

31329599B (Exp 09/2023)

Date Ranges: 10/2021, 11/2021, 08/2023, 09/2023

Product: Alprostadil Injection USP, 500 mg/mL, 1 mL single dose vials

Model:

NDC 0703-1501-02

NDC 0703-1501-01

Lot Numbers:

31329295B (Exp 01/2022)

Date Ranges: 01/2022

Product: Methylprednisolone Acetate Injectable Suspension USP, 80 mg/mL (1mL, 5mL)

Model:

NDC 0703-0051-01

NDC 0703-0063-01

Lot Numbers:

31329363B (Exp 01/2022)

31329484B (Exp 03/2022)

31328367B (Exp 07/2021)

31328431B (Exp 07/2021)

31329014B (Exp 11/2021)

Date Ranges: 07/2021, 11/2021, 01/2022, 03/2022

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 88442

Status: Resolved

Manufacturer: Teva Pharmaceuticals USA

Sold By: NorthStar Rx LLC; Teva Parenteral Medicines, Inc.; Teva Pharmaceuticals USA, Inc.

Manufactured In: United States

Distributed To: Nationwide