Medications & Supplements/Prescription Drugs

Hikma Pharmaceuticals USA Inc.: Bleomycin for Injection Recalled Due to Mislabeling

Agency Publication Date: August 26, 2021

Summary

Hikma Pharmaceuticals USA Inc. is recalling 1,152 vials of Bleomycin for Injection, USP (15 units per single-dose vial). This prescription medication is being recalled because of a labeling error, categorized as mislabeling not elsewhere classified. Consumers should be aware that the 1,152 affected vials were distributed nationwide across the United States.

Risk

The product is mislabeled, which could lead to confusion regarding the medication's identity, strength, or administration instructions. This poses a risk to patient safety as it may result in improper dosing or the administration of the wrong medication.

What You Should Do

Locate your medication and check the label for 'Bleomycin for Injection, USP' in 15 units per single-dose vial format.
Verify the NDC number 0143-9240-01 and the specific lot number BL0018 on the vial or packaging.
If your medication matches lot number BL0018, contact your healthcare provider or pharmacist immediately for guidance on whether to continue use or to obtain a replacement.
Return any unused vials from the affected lot to your pharmacy to receive a refund.
Contact Hikma Pharmaceuticals USA Inc. at their Cherry Hill, NJ office if you have specific questions regarding this recall.
For further information or to report adverse events, 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 refund.

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

Affected Products

Product: Bleomycin for Injection, USP (15 units per single dose vial)

Model:

NDC 0143-9240-01

Lot Numbers:

BL0018

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 88402

Status: Resolved

Manufacturer: Hikma Pharmaceuticals USA Inc.

Sold By: Pharmacies; Healthcare providers

Manufactured In: Germany, United States

Units Affected: 1,152 vials

Distributed To: Nationwide

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

Locate your medication and check the label for 'Bleomycin for Injection, USP' in 15 units per single-dose vial format.

Verify the NDC number 0143-9240-01 and the specific lot number BL0018 on the vial or packaging.

If your medication matches lot number BL0018, contact your healthcare provider or pharmacist immediately for guidance on whether to continue use or to obtain a replacement.

Return any unused vials from the affected lot to your pharmacy to receive a refund.

Contact Hikma Pharmaceuticals USA Inc. at their Cherry Hill, NJ office if you have specific questions regarding this recall.

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