Why it was recalled
Failed Tablet/Capsule Specifications: Tablets were observed to have an unsmooth surface with two tablets demonstrating illegible tablet identification and scoring.
Product description
Methotrexate Tablets, USP, 2.5 mg, 10x10 Unit-Dose Tablets per carton, Rx only, Distributed by: West-Ward Pharmaceuticals Corp., Eatontown, NJ 07724. NDC: 0054-8550-25
Lot numbers, UPCs & expiration codes
Lot, expiry: Lot AB7486B, exp Dec 2023; Lot AB8766B, exp April 2024; Lot AB9484B, exp Aug 2024
Where it was sold
MS, OH
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-0066-2024
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- Sep 22, 2023
- FDA report date
- Nov 1, 2023
- Quantity
- 2,673 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- West-Ward Columbus Inc
Original FDA data
Every field from FDA enforcement report D-0066-2024, exactly as published.
Show all FDA fields
- City
- Columbus
- State
- OH
- Status
- Ongoing
- Country
- United States
- Event ID
- 93223
- Address
- 1809 Wilson Rd
- Code information
- Lot, expiry: Lot AB7486B, exp Dec 2023; Lot AB8766B, exp April 2024; Lot AB9484B, exp Aug 2024
- Postal code
- 43228-9579
- Report date
- Nov 1, 2023
- Product type
- Drugs
- Recall number
- D-0066-2024
- Classification
- Class III
- Recalling firm
- West-Ward Columbus Inc
- Product quantity
- 2,673 cartons
- Reason for recall
- Failed Tablet/Capsule Specifications: Tablets were observed to have an unsmooth surface with two tablets demonstrating illegible tablet identification and scoring.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Methotrexate Tablets, USP, 2.5 mg, 10x10 Unit-Dose Tablets per carton, Rx only, Distributed by: West-Ward Pharmaceuticals Corp., Eatontown, NJ 07724. NDC: 0054-8550-25
- Distribution pattern
- MS, OH
- Recall initiation date
- Sep 22, 2023
- Initial firm notification
- Letter
- Center classification date
- Oct 23, 2023