Why it was recalled
Failed Tablet/Capsule Specifications: Tablets are imprinted with the incorrect identification code.
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
Lot numbers, UPCs & expiration codes
Lot: #064046A, Exp. 03/2022
Where it was sold
OH and MS
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1490-2020
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jul 22, 2020
- FDA report date
- Aug 19, 2020
- Quantity
- 2300 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- West-Ward Columbus Inc
Original FDA data
Every field from FDA enforcement report D-1490-2020, exactly as published.
Show all FDA fields
- City
- Columbus
- State
- OH
- Status
- Terminated
- Country
- United States
- Event ID
- 86079
- Address
- 1809 Wilson Rd
- Code information
- Lot: #064046A, Exp. 03/2022
- Postal code
- 43228-9579
- Report date
- Aug 19, 2020
- Product type
- Drugs
- Recall number
- D-1490-2020
- Classification
- Class III
- Recalling firm
- West-Ward Columbus Inc
- Product quantity
- 2300 bottles
- Termination date
- Aug 12, 2022
- Reason for recall
- Failed Tablet/Capsule Specifications: Tablets are imprinted with the incorrect identification code.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- OH and MS
- Recall initiation date
- Jul 22, 2020
- Initial firm notification
- Letter
- Center classification date
- Aug 7, 2020