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
Reason for recall: Failed Impurities/Degradation Specification: Out of specification for organic impurities
Recall initiated: 20240116
Status: Ongoing
Classification: Class II
Recall type: Voluntary: Firm initiated