Recalls / Class III
Class IIID-1490-2020
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
- Brand name
- Leucovorin Calcium
- Generic name
- Leucovorin Calcium
- Active ingredient
- Leucovorin Calcium
- Route
- Oral
- NDCs
- 0054-4496, 0054-4497, 0054-4498, 0054-4499, 0054-8496
- FDA application
- ANDA072733
- Affected lot / code info
- Lot: #064046A, Exp. 03/2022
Why it was recalled
Failed Tablet/Capsule Specifications: Tablets are imprinted with the incorrect identification code.
Recalling firm
- Firm
- West-Ward Columbus Inc
- Manufacturer
- Hikma Pharmaceuticals USA Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1809 Wilson Rd, N/A, Columbus, Ohio 43228-9579
Distribution
- Quantity
- 2300 bottles
- Distribution pattern
- OH and MS
Timeline
- Recall initiated
- 2020-07-22
- FDA classified
- 2020-08-07
- Posted by FDA
- 2020-08-19
- Terminated
- 2022-08-12
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1490-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.