Class III
Terminated
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
- Company
- Ascend Laboratories, Llc
- Recall Initiated
- July 18, 2023
- Posted
- September 13, 2023
- Recall Number
- D-1145-2023
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 99,516 sachets
- Firm Location
- Parsippany, NJ, United States
Reason for Recall
Failed Impurities/Degradation Specifications: Out-of-specification results observed for the organic impurities test at 6 months, RT Stability.
Distribution
The recall product was distributed nationwide.
Lot / Code Info
Lot #22121970, 22122158, 22121971, 22122189, 22122190, 22122277, 22122278, Exp June 2024; 22122521, 22122522, 22122523, Exp July 2024; 22123328, 22123329, 22123330, Exp September 2024.
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