Medications & Supplements/Prescription Drugs

Teva Pharmaceuticals USA: Topotecan Injection Recalled for Presence of Glass, Silicone, and Cotton Fiber

Agency Publication Date: July 7, 2021

Summary

Teva Pharmaceuticals USA is recalling approximately 10,425 vials of Topotecan Injection 4 mg/4mL (1 mg/mL) after a complaint revealed a glass particle inside a vial. Subsequent analysis of the returned product found additional foreign particles, specifically a grey silicone particle and a translucent cotton fiber. Consumers and healthcare providers should check for affected single-dose vials with lot number 31328962B and an expiration date of 04/2022 that were distributed nationwide.

Risk

The presence of foreign particulate matter in an injectable drug can cause serious health risks, including local irritation, swelling, or the formation of blood clots that can travel to vital organs and cause life-threatening complications like a stroke or heart attack.

What You Should Do

Check your supply for Topotecan Injection 4 mg/4mL (1 mg/mL) in single-dose vials with Carton NDC# 0703-4714-01 or Vial NDC# 0703-4714-71.
Identify if your product is affected by looking for Lot # 31328962B with an expiration date of 04/2022.
If you have an affected vial, stop using it immediately and do not administer it to any patients.
Contact your healthcare provider or pharmacist for guidance regarding this recall and your treatment.
Return any unused or affected vials to the pharmacy where they were purchased for a refund.
Contact Teva Pharmaceuticals USA at their distributor address at 400 Interpace Pkwy, Parsippany, New Jersey for further instructions regarding the return process.
For additional questions, 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 provider consultation and pharmacy return

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

Affected Products

Product: Topotecan Injection 4 mg/4mL (1 mg/mL), Single-Dose vial

Model:

Carton NDC# 0703-4714-01

Vial NDC# 0703-4714-71

Lot Numbers:

31328962B (Exp 04/2022)

Date Ranges: Expiration date 04/2022

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 88154

Status: Resolved

Manufacturer: Teva Pharmaceuticals USA

Sold By: Nationwide distributors

Manufactured In: United States

Units Affected: 10,425 vials

Distributed To: Nationwide

Agency Last Updated: July 15, 2021

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

Check your supply for Topotecan Injection 4 mg/4mL (1 mg/mL) in single-dose vials with Carton NDC# 0703-4714-01 or Vial NDC# 0703-4714-71.

Identify if your product is affected by looking for Lot # 31328962B with an expiration date of 04/2022.

If you have an affected vial, stop using it immediately and do not administer it to any patients.

Contact your healthcare provider or pharmacist for guidance regarding this recall and your treatment.

Return any unused or affected vials to the pharmacy where they were purchased for a refund.

Contact Teva Pharmaceuticals USA at their distributor address at 400 Interpace Pkwy, Parsippany, New Jersey for further instructions regarding the return process.

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