Drug product
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
D-0066-2024
Product summary
- Event
- Event 93223
- Status
- Ongoing
- Classification
- Class III
- Quantity
- 2,673 cartons
- Official record key
drug-enforcement:D-0066-2024
Official wording
Reason: Failed Tablet/Capsule Specifications: Tablets were observed to have an unsmooth surface with two tablets demonstrating illegible tablet identification and scoring.
Code information: Lot, expiry: Lot AB7486B, exp Dec 2023; Lot AB8766B, exp April 2024; Lot AB9484B, exp Aug 2024
Distribution pattern: MS, OH
Derived failure modes
-
Unknown
Failed Tablet/Capsule Specifications: Tablets were observed to have an unsmooth surface with two tablets demonstrating illegible tablet identification and scoring.