FDA-Drug2023-09-13Class III
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
Ascend Laboratories, LLC
Hazard
Failed Impurities/Degradation Specifications: Out-of-specification results observed for the organic impurities test at 6 months, RT Stability.
Sold states
The recall product was distributed nationwide.
Affected count
99,516 sachets
Manufactured in
339 Jefferson Rd Ste 101, N/A, Parsippany, NJ, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1145-2023Don't want to check this manually?
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