July 2020 FDA Recall Leucovorin Calcium by West-ward Columbus Inc
D-1490-2020 - Failed Tablet/Capsule Specifications
This Class III drug recall was voluntarily initiated by West-ward Columbus Inc on July 22, 2020 for the product Leucovorin Calcium. The FDA reported the reason for recall as failed tablet/capsule specifications. The product was distributed in OH and MS and the recall is currently terminated.
Recall Number: D-1490-2020
Failed Tablet/Capsule Specifications: Tablets are imprinted with the incorrect identification code.
07-22-2020
08-19-2020
2300 bottles
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
West-Ward Columbus Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
OH and MS
08-12-2022
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Leucovorin Calcium Tablets USP, 10 mg, Rx only, 24 Tablets per bottle, Distr. by: West-Ward Pharmaceuticals Corp. Eatontown, NJ 07724, NDC 0054-4497-10
Batch or Lot Expiration Information
Lot# Lot: #064046A, Exp. 03/2022
