Drug recall D-0339-2024

Class II Ongoing reported Feb 28, 2024

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

Lots and codes

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.

Recall details

Recalling firm
Ascend Laboratories, LLC, Parsippany, NJ
Quantity
71,244 sachets
Distribution
Nationwide in the USA
Type
Voluntary: Firm initiated
Recall initiated
January 16, 2024

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