D-0629-2024 Class III
FDA drug recall D-0629-2024 was initiated by Amneal Pharmaceuticals, LLC on August 1, 2024 and is designated Class III. Reason for recall: Presence of Foreign Tablets: Potential presence of Fludrocortisone Acetate Tablet USP 0.1 mg within the Methotrexate 2.5 mg 100-count Bottle. Affected quantity: 12,624 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- August 14, 2024
- Initiation Date
- August 1, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 12,624 bottles
Product Description
Methotrexate Tablets, USP, 2.5mg, 100-count Bottle, RX Only, Distributed By: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC# 69238-1423-1
Reason for Recall
Presence of Foreign Tablets: Potential presence of Fludrocortisone Acetate Tablet USP 0.1 mg within the Methotrexate 2.5 mg 100-count Bottle.
Distribution Pattern
Nationwide in the USA
Code Information
Lot # BB29124, Exp. 02/28/2026