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Class II Recall
Ascend Laboratories, LLC
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
Failed Impurities/Degradation Specification: Out of specification for organic impurities
Classification
Class II
Status
Ongoing
Lot
lOTS #: 22121458, 22121459, 22121460, 22121461, 22121462, 22121463, 22121464, Exp 4/2024; 22121176, 22121407, 22121465, Exp 3/2024; 22121761, 22121762, 22121763, 22121764, 22121766, 22121968, 22121969, Exp 5/2024.
Date
2024-02-28
Disclaimer:
This tool indexes published US FDA drug-enforcement recall records from all countries, limited to the latest five years. A company or product not appearing here is not proof that it is compliant, approved, safe, or free of FDA action.