Ascend Laboratories, LLC recalls Fosfomycin Tromethamine Granules for Oral Solution, 3 g single- dose sachet, Rx only, Manufactured by: Alkem Laboratorie
Recalled September 13, 2023 · FDA recall D-1145-2023 · Ascend Laboratories
Hazard
Failed Impurities/Degradation Specifications: Out-of-specification results observed for the organic impurities test at 6 months, RT Stability. · FDA Class III
Units
99,516 sachets
Sold at
The recall product was distributed nationwide.
Description
Failed Impurities/Degradation Specifications: Out-of-specification results observed for the organic impurities test at 6 months, RT Stability.
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
Manufacturer(s)
Ascend Laboratories, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →