Ascend Laboratories, LLC recalls Fosfomycin Tromethamine Granules for Oral Solution, (equivalent to 3 grams of fosfomycin), single-dose sachet, Rx Only,
Recalled February 28, 2024 · FDA recall D-0339-2024 · Ascend Laboratories
Hazard
Failed Impurities/Degradation Specification: Out of specification for organic impurities · FDA Class II
Units
71,244 sachets
Sold at
Nationwide in the USA
Description
Failed Impurities/Degradation Specification: Out of specification for organic impurities
Product
Fosfomycin Tromethamine Granules for Oral Solution, (equivalent to 3 grams of fosfomycin), 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 →