Medications & Supplements/Prescription Drugs

West-Ward Columbus Inc: Leucovorin Calcium Tablets Recalled for Incorrect Identification Codes

Agency Publication Date: August 7, 2020

Summary

West-Ward Columbus Inc. is recalling 2,300 bottles of Leucovorin Calcium Tablets USP, 10 mg (generic for Wellcovorin). These prescription tablets are being recalled because they are imprinted with the incorrect identification code on the pill itself, which does not match the product's specifications. This error could lead to confusion regarding the medication's identity.

Risk

The incorrect identification code on the tablets poses a risk of medication error, as patients or healthcare providers may not be able to correctly identify the drug or may mistake it for a different strength or medication.

What You Should Do

Check your medication bottle to see if it is Leucovorin Calcium Tablets USP, 10 mg, distributed in 24-count bottles with NDC 0054-4497-10.
Look for lot number 064046A with an expiration date of 03/2022 printed on the label.
If your bottle matches this lot and NDC, contact your healthcare provider or pharmacist immediately to discuss your treatment and verify your medication.
Return any unused tablets from this specific lot to the pharmacy where you purchased them for a refund.
Contact the manufacturer, West-Ward Columbus Inc., for further instructions regarding 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

Pharmacy refund and healthcare consultation

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 Tablets USP, 10 mg (24 Tablets per bottle)

Model:

NDC 0054-4497-10

Recall #: D-1490-2020

Lot Numbers:

064046A (Exp. 03/2022)

Date Ranges: Exp. 03/2022

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 86079

Status: Resolved

Manufacturer: West-Ward Columbus Inc

Sold By: West-Ward Pharmaceuticals Corp.

Manufactured In: United States

Units Affected: 2300 bottles

Distributed To: Ohio, Mississippi

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 bottle to see if it is Leucovorin Calcium Tablets USP, 10 mg, distributed in 24-count bottles with NDC 0054-4497-10.

Look for lot number 064046A with an expiration date of 03/2022 printed on the label.

If your bottle matches this lot and NDC, contact your healthcare provider or pharmacist immediately to discuss your treatment and verify your medication.

Return any unused tablets from this specific lot to the pharmacy where you purchased them for a refund.

Contact the manufacturer, West-Ward Columbus Inc., for further instructions regarding 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.