Medications & Supplements/Prescription Drugs

Ingenus Pharmaceuticals Llc: Irinotecan Hydrochloride Injection Recalled for Superpotency Risk

Agency Publication Date: June 29, 2018

Summary

Ingenus Pharmaceuticals is recalling approximately 49,053 vials of Irinotecan Hydrochloride Injection, USP, which is used in cancer treatment. The recall was initiated because laboratory testing found the medication to be 'superpotent,' meaning it contains a higher concentration of the active drug than specified on the label. This potency issue was identified through 'out of specification' assay results, which can lead to patients receiving an unintended and potentially dangerous dose of the medication. This recall affects two different vial sizes distributed nationwide.

Risk

Because the drug is superpotent, patients may receive a higher dose than prescribed, which significantly increases the risk of severe side effects associated with Irinotecan, including severe diarrhea and bone marrow suppression (which lowers the body's ability to fight infection).

What You Should Do

Check your medication vials for Irinotecan Hydrochloride Injection, USP, 100 mg/5 mL (20 mg/mL). Affected vials have NDC 50742-402-05 and belong to lot numbers 17034-1, 17035-1, or 17036-1 with an expiration date of 08/19.
Check your medication vials for Irinotecan Hydrochloride Injection, USP, 40 mg/2 mL (20 mg/mL). Affected vials have NDC 50742-401-02 and belong to lot numbers 17034-2, 17035-2, or 17036-2 with an expiration date of 08/19.
If you identify an affected vial, contact your healthcare provider or pharmacist immediately for guidance on your treatment and to arrange for a safe alternative.
Return any unused vials from the affected lots to the pharmacy where you purchased them to receive a refund and ensure the product is properly handled.
Contact Ingenus Pharmaceuticals Llc at their Orlando, Florida headquarters for further instructions regarding the return of these specific lots.
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 product to place of purchase.

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

Affected Products

Product: Irinotecan Hydrochloride Injection, USP, 100 mg/5 mL (20 mg/mL)

Model:

NDC 50742-402-05

Recall #: D-0890-2018

Lot Numbers:

17034-1 (Exp. 08/19)

17035-1 (Exp. 08/19)

17036-1 (Exp. 08/19)

Date Ranges: Expiration date 08/2019

Product: Irinotecan Hydrochloride Injection, USP, 40 mg/2 mL (20 mg/mL)

Model:

NDC 50742-401-02

Recall #: D-0891-2018

Lot Numbers:

17034-2 (Exp. 08/19)

17035-2 (Exp. 08/19)

17036-2 (Exp. 08/19)

Date Ranges: Expiration date 08/2019

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 80254

Status: Resolved

Manufacturer: Ingenus Pharmaceuticals Llc

Sold By: Pharmacies; Hospitals

Manufactured In: Switzerland, United States

Units Affected: 2 products (34964 vials; 14089 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

What You Should Do

Check your medication vials for Irinotecan Hydrochloride Injection, USP, 100 mg/5 mL (20 mg/mL). Affected vials have NDC 50742-402-05 and belong to lot numbers 17034-1, 17035-1, or 17036-1 with an expiration date of 08/19.

Check your medication vials for Irinotecan Hydrochloride Injection, USP, 40 mg/2 mL (20 mg/mL). Affected vials have NDC 50742-401-02 and belong to lot numbers 17034-2, 17035-2, or 17036-2 with an expiration date of 08/19.

If you identify an affected vial, contact your healthcare provider or pharmacist immediately for guidance on your treatment and to arrange for a safe alternative.

Return any unused vials from the affected lots to the pharmacy where you purchased them to receive a refund and ensure the product is properly handled.

Contact Ingenus Pharmaceuticals Llc at their Orlando, Florida headquarters for further instructions regarding the return of these specific lots.

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 Hydrochloride Injection, USP, 100 mg/5 mL (20 mg/mL)

Model:

NDC 50742-402-05

Recall #: D-0890-2018

Lot Numbers:

17034-1 (Exp. 08/19)

17035-1 (Exp. 08/19)

17036-1 (Exp. 08/19)

Date Ranges: Expiration date 08/2019

Product: Irinotecan Hydrochloride Injection, USP, 40 mg/2 mL (20 mg/mL)

Model:

NDC 50742-401-02

Recall #: D-0891-2018

Lot Numbers:

17034-2 (Exp. 08/19)

17035-2 (Exp. 08/19)

17036-2 (Exp. 08/19)

Date Ranges: Expiration date 08/2019