Drug product
Methotrexate Tablets, USP, 2.5mg, 100-count Bottle, RX Only, Distributed By: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC# 69238-1423-1
D-0629-2024
Product summary
- Event
- Event 95082
- Status
- Completed
- Classification
- Class III
- Quantity
- 12,624 bottles
- Official record key
drug-enforcement:D-0629-2024
Official wording
Reason: Presence of Foreign Tablets: Potential presence of Fludrocortisone Acetate Tablet USP 0.1 mg within the Methotrexate 2.5 mg 100-count Bottle.
Code information: Lot # BB29124, Exp. 02/28/2026
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Foreign material or chemical contamination
Foreign Tablets