FDARecalled Sep 13, 2023 · #D-1145-2023
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...
Hazard
Class III — low health risk
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Failed Impurities/Degradation Specifications: Out-of-specification results observed for the organic impurities test at 6 months, RT Stability. Classification: Class III Distribution: The recall product was distributed nationwide.
Product details
- 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
- Type
- Drugs
- Manufacturer
- Ascend Laboratories, LLC
- Model numbers
- 22121970
- UPCs
- —