Medications & Supplements/Prescription Drugs

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

Agency Publication Date: February 21, 2021

Summary

Teva Pharmaceuticals USA has voluntarily recalled approximately 1.4 million vials of various sterile injectable medications, including Dacarbazine, Desmopressin Acetate, Epoprostenol Sodium, Methylprednisolone Acetate, Leucovorin Calcium, Metoclopramide, Toposar, and Vecuronium Bromide. These products were recalled because the manufacturing areas exceeded acceptable levels for microbial recovery, meaning there is no longer a guarantee that these injectable drugs are sterile. Patients should check their medication labels against the specific lot numbers and expiration dates provided to ensure they do not have affected medicine.

Risk

Using a medication that lacks sterility assurance can lead to serious infections, especially when the drug is administered directly into the bloodstream or muscle. While no injuries have been reported to date, the presence of microorganisms in sterile injectable products poses a significant health risk to patients.

What You Should Do

Check your medication vials and packaging for the following product names and lot numbers: Dacarbazine (31326582B, 31326964B), Desmopressin (31326669B), Epoprostenol (31326845B, 31327844B, 31327537B, 31326456B), Methylprednisolone (31327742B, 31328408B, 31327909B, 31328352B, 31327725B, 31327906B, 31328768B, 31327738B), Leucovorin (31326364B, 31327120B, 31327963B, 31324653B, 31326066B, 31326428B, 31327949B, 31327995B, 31328031B, 31328217B, 31328325B, 31328425B, 31324480B, 31327396B), Metoclopramide (31325042B, 31325336B, 31326042B, 31326137B, 31326230B, 31323816B), Toposar (31327600B), and Vecuronium Bromide (31325712B, 31326320B, 31326457B, 31327880B).
If you identify an affected product, contact your healthcare provider or pharmacist immediately for guidance on alternatives and to report any adverse health effects.
Return any unused, recalled medication to the pharmacy or place of purchase for a full refund.
Contact Teva Pharmaceuticals USA at their distributor address (400 Interpace Pkwy, Parsippany, NJ 07054) for further instructions regarding the return process.
For additional questions or to report a complaint, 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

Healthcare guidance and product refund.

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

Affected Products

Product: Dacarbazine for Injection USP, 200 mg, Single Use Vial

Model:

NDC 0703-5075-01

NDC 0703-5075-03

Lot Numbers:

31326582B (Exp 02/2022)

31326964B (Exp 04/2022)

Product: Desmopressin Acetate Injection USP, 4 mcg/mL, 1 mL Preserved Vial

Model:

NDC 0703-5051-01

NDC 0703-5051-03

Lot Numbers:

31326669B (Exp 03/2021)

Product: Sterile Diluent for Epoprostenol Sodium for Injection, 50 mL vial

Model:

NDC 0703-9258-01

NDC 0703-9258-09

Lot Numbers:

31326845B (Exp 03/2021)

31327844B (Exp 09/2021)

Product: Epoprostenol Sodium for Injection, 0.5 mg/vial (500,000 ng), 10 mL vial

Model:

NDC 0703-1985-01

Lot Numbers:

31327537B (Exp 09/2021)

Product: MethylPREDNISolone Acetate Injectable Suspension USP, 40 mg/mL, 1 mL Single-Dose Vial

Model:

NDC 0703-0031-01

NDC 0703-0031-04

Lot Numbers:

31327742B (Exp 02/2021)

31328408B (Exp 07/2021)

Product: Leucovorin Calcium for Injection, USP, 100 mg/vial, Single-Dose Vial

Model:

NDC 0703-5140-01

Lot Numbers:

31326364B (Exp 01/2022)

31327120B (Exp 05/2022)

31327963B (Exp 10/2022)

Product: Metoclopramide Injection USP, 10 mg/2 mL (5 mg/mL), 2 mL Single-Use Vial

Model:

NDC 0703-4502-01

NDC 0703-4502-04

Lot Numbers:

31325042B (Exp 06/2021)

31325336B (Exp 07/2021)

31326042B (Exp 10/2021)

31326137B (Exp 11/2021)

31326230B (Exp 12/2021)

31323816B (Exp 02/2021)

Product: Toposar (etoposide injection USP), 1 gram/50 mL (20 mg/mL), 50 mL Multiple-dose Vial

Model:

NDC 0703-5657-01

Lot Numbers:

31327600B (Exp 08/2022)

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

Model:

NDC 0703-2914-01

NDC 0703-2914-03

Lot Numbers:

31325712B (Exp 12/2021)

31326320B (Exp 02/2022)

31326457B (Exp 02/2022)

31327880B (Exp 10/2022)

Product: Epoprostenol Sodium for Injection, 1.5 mg/vial (1,500,000 ng), 10 mL vial

Model:

NDC 0703-1995-01

Lot Numbers:

31326456B (Exp 02/28/2021)

Product: MethylPREDNISolone Acetate Injectable Suspension USP, 80 mg/mL, 1 mL Single-Dose Vial

Model:

NDC 0703-0051-01

NDC 0703-0051-04

Lot Numbers:

31327909B (Exp 04/2021)

31328352B (Exp 07/2021)

Product: MethylPREDNISolone Acetate Injectable Suspension USP, 400 mg/10 mL (40 mg/mL), 10 mL Multiple-Dose Vial

Model:

NDC 0703-0045-01

Lot Numbers:

31327725B (Exp 02/2021)

31327906B (Exp 03/2021)

Product: MethylPREDNISolone Acetate Injectable Suspension USP, 200 mg/5 mL (40 mg/mL), 5 mL Multiple-Dose Vial

Model:

NDC 0703-0043-01

Lot Numbers:

31328768B (Exp 09/2021)

Product: MethylPREDNISolone Acetate Injectable Suspension USP, 400 mg/5 mL (80 mg/mL), 5 mL Multiple-Dose Vial

Model:

NDC 0703-0063-01

Lot Numbers:

31327738B (Exp 03/2021)

Product: Leucovorin Calcium for Injection, USP, 350 mg/vial

Model:

NDC 0703-5145-01

Lot Numbers:

31324653B (Exp 03/2021)

31326066B (Exp 11/2021)

31326428B (Exp 02/2022)

31327949B (Exp 10/2022)

31327995B (Exp 10/2022)

31328031B (Exp 11/2022)

31328217B (Exp 12/2022)

31328325B (Exp 12/2022)

31328425B (Exp 07/2021)

31324480B (Exp 02/2021)

31327396B (Exp 08/2022)

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 87298

Status: Resolved

Manufacturer: Teva Pharmaceuticals USA

Sold By: Hospitals; Pharmacies; Healthcare Clinics

Manufactured In: United States

Units Affected: 14 products (50 vials; 2,577 vials; 26,373 vials; 12,629 vials; 5,086 vials; 248,565 vials; 29,357 vials; 4,806 vials; 33,6697 vials; 12,609 vials; 5,378 vials; 6,710 vials; 15,043 vials; 705,745 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

Risk

What You Should Do

Check your medication vials and packaging for the following product names and lot numbers: Dacarbazine (31326582B, 31326964B), Desmopressin (31326669B), Epoprostenol (31326845B, 31327844B, 31327537B, 31326456B), Methylprednisolone (31327742B, 31328408B, 31327909B, 31328352B, 31327725B, 31327906B, 31328768B, 31327738B), Leucovorin (31326364B, 31327120B, 31327963B, 31324653B, 31326066B, 31326428B, 31327949B, 31327995B, 31328031B, 31328217B, 31328325B, 31328425B, 31324480B, 31327396B), Metoclopramide (31325042B, 31325336B, 31326042B, 31326137B, 31326230B, 31323816B), Toposar (31327600B), and Vecuronium Bromide (31325712B, 31326320B, 31326457B, 31327880B).

If you identify an affected product, contact your healthcare provider or pharmacist immediately for guidance on alternatives and to report any adverse health effects.

Return any unused, recalled medication to the pharmacy or place of purchase for a full refund.

Contact Teva Pharmaceuticals USA at their distributor address (400 Interpace Pkwy, Parsippany, NJ 07054) for further instructions regarding the return process.

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

Affected Products

Product: Dacarbazine for Injection USP, 200 mg, Single Use Vial

Model:

NDC 0703-5075-01

NDC 0703-5075-03

Lot Numbers:

31326582B (Exp 02/2022)

31326964B (Exp 04/2022)

Product: Desmopressin Acetate Injection USP, 4 mcg/mL, 1 mL Preserved Vial

Model:

NDC 0703-5051-01

NDC 0703-5051-03

Lot Numbers:

31326669B (Exp 03/2021)

Product: Sterile Diluent for Epoprostenol Sodium for Injection, 50 mL vial

Model:

NDC 0703-9258-01

NDC 0703-9258-09

Lot Numbers:

31326845B (Exp 03/2021)

31327844B (Exp 09/2021)

Product: Epoprostenol Sodium for Injection, 0.5 mg/vial (500,000 ng), 10 mL vial

Model:

NDC 0703-1985-01

Lot Numbers:

31327537B (Exp 09/2021)

Product: MethylPREDNISolone Acetate Injectable Suspension USP, 40 mg/mL, 1 mL Single-Dose Vial

Model:

NDC 0703-0031-01

NDC 0703-0031-04

Lot Numbers:

31327742B (Exp 02/2021)

31328408B (Exp 07/2021)

Product: Leucovorin Calcium for Injection, USP, 100 mg/vial, Single-Dose Vial

Model:

NDC 0703-5140-01

Lot Numbers:

31326364B (Exp 01/2022)

31327120B (Exp 05/2022)

31327963B (Exp 10/2022)

Product: Metoclopramide Injection USP, 10 mg/2 mL (5 mg/mL), 2 mL Single-Use Vial

Model:

NDC 0703-4502-01

NDC 0703-4502-04

Lot Numbers:

31325042B (Exp 06/2021)

31325336B (Exp 07/2021)

31326042B (Exp 10/2021)

31326137B (Exp 11/2021)

31326230B (Exp 12/2021)

31323816B (Exp 02/2021)

Product: Toposar (etoposide injection USP), 1 gram/50 mL (20 mg/mL), 50 mL Multiple-dose Vial

Model:

NDC 0703-5657-01

Lot Numbers:

31327600B (Exp 08/2022)

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

Model:

NDC 0703-2914-01

NDC 0703-2914-03

Lot Numbers:

31325712B (Exp 12/2021)

31326320B (Exp 02/2022)

31326457B (Exp 02/2022)

31327880B (Exp 10/2022)

Product: Epoprostenol Sodium for Injection, 1.5 mg/vial (1,500,000 ng), 10 mL vial

Model:

NDC 0703-1995-01

Lot Numbers:

31326456B (Exp 02/28/2021)

Product: MethylPREDNISolone Acetate Injectable Suspension USP, 80 mg/mL, 1 mL Single-Dose Vial

Model:

NDC 0703-0051-01

NDC 0703-0051-04

Lot Numbers:

31327909B (Exp 04/2021)

31328352B (Exp 07/2021)

Product: MethylPREDNISolone Acetate Injectable Suspension USP, 400 mg/10 mL (40 mg/mL), 10 mL Multiple-Dose Vial

Model:

NDC 0703-0045-01

Lot Numbers:

31327725B (Exp 02/2021)

31327906B (Exp 03/2021)

Product: MethylPREDNISolone Acetate Injectable Suspension USP, 200 mg/5 mL (40 mg/mL), 5 mL Multiple-Dose Vial

Model:

NDC 0703-0043-01

Lot Numbers:

31328768B (Exp 09/2021)

Product: MethylPREDNISolone Acetate Injectable Suspension USP, 400 mg/5 mL (80 mg/mL), 5 mL Multiple-Dose Vial

Model:

NDC 0703-0063-01

Lot Numbers:

31327738B (Exp 03/2021)

Product: Leucovorin Calcium for Injection, USP, 350 mg/vial

Model:

NDC 0703-5145-01

Lot Numbers:

31324653B (Exp 03/2021)

31326066B (Exp 11/2021)

31326428B (Exp 02/2022)

31327949B (Exp 10/2022)

31327995B (Exp 10/2022)

31328031B (Exp 11/2022)

31328217B (Exp 12/2022)

31328325B (Exp 12/2022)

31328425B (Exp 07/2021)

31324480B (Exp 02/2021)

31327396B (Exp 08/2022)

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 87298

Status: Resolved

Manufacturer: Teva Pharmaceuticals USA

Sold By: Hospitals; Pharmacies; Healthcare Clinics

Manufactured In: United States

Distributed To: Nationwide