Medications & Supplements/Prescription Drugs

Ingenus Pharmaceuticals Llc: Leucovorin Calcium Injection Recalled for API Crystallization

Agency Publication Date: October 17, 2019

Summary

Ingenus Pharmaceuticals is recalling 16,485 vials of Leucovorin Calcium Injection, USP 500 mg/50 mL (10 mg/mL). This prescription medication is being recalled because the Active Pharmaceutical Ingredient (API) has crystallized, causing solid particulate matter to form inside the single-dose vials. Consumers should contact their healthcare provider or pharmacist immediately regarding this recall, as the presence of crystals in an injectable drug can lead to serious health complications.

Risk

The presence of crystals or particulate matter in an intravenous injection can cause local inflammation, blockages in blood vessels, or more severe systemic reactions if the solids travel through the bloodstream.

What You Should Do

Check your medical supplies for Leucovorin Calcium Injection, USP 500 mg/50 mL (10 mg/mL) in 50 mL single-dose vials with NDC 50742-464-50.
Specifically look for the following affected lot numbers and expiration dates: Lot 18048 (Exp. 04/2020), Lot 18049 (Exp. 04/2020), Lot 18050 (Exp. 05/2020), or Lot 19036 (Exp. 12/2020).
If you have an affected vial, do not use it. Contact your healthcare provider or pharmacist for guidance on alternative treatments and instructions on how to return the product.
Contact your pharmacy or place of purchase to arrange for a refund of any unused medication from the affected lots.
Contact Ingenus Pharmaceuticals LLC for further instructions or to report any issues related to this recall.
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 refund.

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

Affected Products

Product: Leucovorin Calcium Injection, USP 500 mg/50 mL (10 mg/mL) 50 mL Single-Dose Vial

Model:

NDC 50742-464-50

Lot Numbers:

18048 (Exp. 04/2020)

18049 (Exp. 04/2020)

18050 (Exp. 05/2020)

19036 (Exp. 12/2020)

Date Ranges: Exp. 04/2020, Exp 05/2020, Exp 12/2020

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 84011

Status: Resolved

Manufacturer: Ingenus Pharmaceuticals Llc

Manufactured In: United States

Units Affected: 16485 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 medical supplies for Leucovorin Calcium Injection, USP 500 mg/50 mL (10 mg/mL) in 50 mL single-dose vials with NDC 50742-464-50.

Specifically look for the following affected lot numbers and expiration dates: Lot 18048 (Exp. 04/2020), Lot 18049 (Exp. 04/2020), Lot 18050 (Exp. 05/2020), or Lot 19036 (Exp. 12/2020).

If you have an affected vial, do not use it. Contact your healthcare provider or pharmacist for guidance on alternative treatments and instructions on how to return the product.

Contact your pharmacy or place of purchase to arrange for a refund of any unused medication from the affected lots.

Contact Ingenus Pharmaceuticals LLC for further instructions or to report any issues related to this recall.

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