Medications & Supplements/Prescription Drugs

Teva Pharmaceuticals USA: Romidepsin Injection Recalled Due to Failed Impurity and Degradation Tests

Agency Publication Date: March 18, 2021

Summary

Teva Pharmaceuticals USA is recalling approximately 1,416 vials of Romidepsin Injection, 27.5 mg/5.5 mL (5 mg/mL). This prescription medication is being recalled because stability testing revealed impurity and degradation levels that were outside of the required specifications. If you have this medication, you should contact your healthcare provider or pharmacist immediately to discuss next steps and return any unused vials to your pharmacy for a refund.

Risk

Impurity and degradation in an injectable medication mean the drug may contain unintended chemical substances or have lost its required strength. This can result in the medication being less effective or causing unexpected side effects for patients undergoing treatment.

What You Should Do

Check your medication to see if you have Romidepsin Injection, 27.5 mg/5.5 mL (5 mg/mL) in 5.5 mL vials with NDC 0703-4004-01.
Verify the lot numbers and expiration dates on the vial: look for Lot # 31328184C (exp. 11/2021), Lot # 31327686C (exp. 08/2021), or Lot # 31327685C (exp. 08/2021).
If your medication matches these lot numbers, contact your healthcare provider or pharmacist immediately for guidance and do not use the product until you have spoken with them.
Return any unused vials to the pharmacy where they were purchased to receive a full refund.
For further instructions or questions regarding this recall, contact Teva Pharmaceuticals USA at their Parsippany, New Jersey location.
Contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for additional assistance.

Your Remedy Options

Full Refund

Healthcare provider consultation and pharmacy refund

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

Affected Products

Product: Romidepsin Injection, 27.5 mg/5.5 mL (5 mg/mL) Rx Only (5.5 ml vial)

Model:

NDC 0703-4004-01

Lot Numbers:

31328184C (exp. 11/2021)

31327686C (exp. 08/2021)

31327685C (exp. 08/2021)

Date Ranges: Expiration dates: 11/2021, 08/2021

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 87452

Status: Resolved

Manufacturer: Teva Pharmaceuticals USA

Manufactured In: United States

Units Affected: 1,416 vials

Distributed To: Nationwide

Agency Last Updated: March 19, 2021

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 medication to see if you have Romidepsin Injection, 27.5 mg/5.5 mL (5 mg/mL) in 5.5 mL vials with NDC 0703-4004-01.

Verify the lot numbers and expiration dates on the vial: look for Lot # 31328184C (exp. 11/2021), Lot # 31327686C (exp. 08/2021), or Lot # 31327685C (exp. 08/2021).

If your medication matches these lot numbers, contact your healthcare provider or pharmacist immediately for guidance and do not use the product until you have spoken with them.

Return any unused vials to the pharmacy where they were purchased to receive a full refund.

For further instructions or questions regarding this recall, contact Teva Pharmaceuticals USA at their Parsippany, New Jersey location.

Contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for additional assistance.