Medications & Supplements/Prescription Drugs

Hikma Pharmaceuticals USA Inc.: Irinotecan HCL Injection Recalled for Defective Container Seals

Agency Publication Date: June 12, 2020

Summary

Hikma Pharmaceuticals USA Inc. is recalling approximately 100,424 vials of Irinotecan HCL Injection, USP (100mg/5mL), a prescription chemotherapy medication. The recall was initiated after customer complaints revealed a crimp defect that occurs when removing the flip-cap during use. This defect involves the container seal and can affect the integrity of the product during administration.

Risk

A defective container seal or crimp can lead to leakage of the medication or compromised sterility. If the seal is not intact, there is a potential risk of exposure to the chemotherapy drug for healthcare workers or contamination of the medicine, which could lead to serious infection or reduced treatment efficacy.

What You Should Do

Check your supply for Irinotecan HCL Injection, USP, 100mg/5mL (5 mL vials) with NDC 0143-9701-01 or NDC 0143-9583-01.
Verify the lot numbers and expiration dates: For NDC 0143-9701-01, look for lot numbers AC0231, AC0235 (Exp. 08/2021), and AC0237 (Exp. 09/2021). For NDC 0143-9583-01, look for lot number AC0231A (Exp. 08/2021).
If you have an affected vial, do not use it; contact your healthcare provider or pharmacist immediately for guidance on alternative supply and treatment.
Return any unused product from the affected lots to your pharmacy or place of purchase for a refund.
Healthcare professionals and patients should contact Hikma Pharmaceuticals USA Inc. at 1-888-723-3332 for further instructions regarding this recall.
For additional questions 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

Return unused product for a refund.

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

Affected Products

Product: Irinotecan HCL Injection, USP, 100mg/5mL (5 mL vial)

Model:

NDC 0143-9701-01

Recall #: D-1308-2020

Lot Numbers:

AC0231 (Exp. 08/2021)

AC0235 (Exp. 08/2021)

AC0237 (Exp. 09/2021)

Date Ranges: 08/2021, 09/2021

Product: Irinotecan HCL Injection, USP, 100mg/5mL (5 mL vial)

Model:

NDC 0143-9583-01

Recall #: D-1309-2020

Lot Numbers:

AC0231A (Exp. 08/2021)

Date Ranges: 08/2021

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 85831

Status: Resolved

Manufacturer: Hikma Pharmaceuticals USA Inc.

Sold By: West-Word Pharmaceutical Corp.; Hospitals; Clinics

Manufactured In: Germany, United States

Units Affected: 2 products (82,426 vials; 17,998 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 supply for Irinotecan HCL Injection, USP, 100mg/5mL (5 mL vials) with NDC 0143-9701-01 or NDC 0143-9583-01.

Verify the lot numbers and expiration dates: For NDC 0143-9701-01, look for lot numbers AC0231, AC0235 (Exp. 08/2021), and AC0237 (Exp. 09/2021). For NDC 0143-9583-01, look for lot number AC0231A (Exp. 08/2021).

If you have an affected vial, do not use it; contact your healthcare provider or pharmacist immediately for guidance on alternative supply and treatment.

Return any unused product from the affected lots to your pharmacy or place of purchase for a refund.

Healthcare professionals and patients should contact Hikma Pharmaceuticals USA Inc. at 1-888-723-3332 for further instructions regarding this recall.

For additional questions 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.

Affected Products

Product: Irinotecan HCL Injection, USP, 100mg/5mL (5 mL vial)

Model:

NDC 0143-9701-01

Recall #: D-1308-2020

Lot Numbers:

AC0231 (Exp. 08/2021)

AC0235 (Exp. 08/2021)

AC0237 (Exp. 09/2021)

Date Ranges: 08/2021, 09/2021

Product: Irinotecan HCL Injection, USP, 100mg/5mL (5 mL vial)

Model:

NDC 0143-9583-01

Recall #: D-1309-2020

Lot Numbers:

AC0231A (Exp. 08/2021)

Date Ranges: 08/2021