Leucovorin Calcium Tablet
FDA Recall NDC 0054-4497
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Leucovorin Calcium (NDC 0054-4497). A significant event, classified as Class III, was initiated on Jul 22, 2020 by Hikma Pharmaceuticals Usa Inc.. The reported reason for this action was: "Failed Tablet/Capsule Specifications: Tablets are imprinted with the incorrect identification code."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class III Terminated
Failed Tablet/Capsule Specifications: Tablets are imprinted with the incorrect identification code.
Jul 22, 2020
Aug 19, 2020
2300 bottles
Recall Profile & Regulatory Data
Event ID
86079
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
West-Ward Columbus Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
OH and MS
Termination Date
Aug 12, 2022
Product Description
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
Affected Packages Involved in this Recall
0054-4496-25Product
0054-4496-13Product
0054-4497-10Product
0054-4497-05Product
0054-4498-10Product
0054-4499-11Product
0054-8496-19Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
