Ascend Laboratories, LLC is recalling 99,516 sachets of Fosfomycin Tromethamine Granules for Oral Solution (3 g), a prescription antibiotic manufactured by Alkem Laboratories Ltd. The recall was initiated after routine stability testing at six months revealed that the medication failed specifications for organic impurities. To date, no incidents or injuries related to this issue have been reported.
The product contains organic impurities and degradation levels that exceed safety specifications, which could potentially impact the quality and effectiveness of the antibiotic treatment.
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Manufactured by Alkem Laboratories Ltd., INDIA; Distributed by Ascend Laboratories, LLC
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Sources: FDA iRES · Raw API Response
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