Drug product
Fosfomycin Tromethamine Granules for Oral Solution, 3 g single- dose sachet, Rx only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC# 67877-749-57
D-1145-2023
Product summary
- Event
- Event 92706
- Status
- Terminated
- Classification
- Class III
- Quantity
- 99,516 sachets
- Official record key
drug-enforcement:D-1145-2023
Official wording
Reason: Failed Impurities/Degradation Specifications: Out-of-specification results observed for the organic impurities test at 6 months, RT Stability.
Code information: Lot #22121970, 22122158, 22121971, 22122189, 22122190, 22122277, 22122278, Exp June 2024; 22122521, 22122522, 22122523, Exp July 2024; 22123328, 22123329, 22123330, Exp September 2024.
Distribution pattern: The recall product was distributed nationwide.
Derived failure modes
-
Potency or specification failure
Out-of-specification