FDA Recall D-0339-2024

Ascend Laboratories, LLC · Parsippany, NJ

Class II Ongoing 849 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

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

Lot / code: 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.

Quantity: 71,244 sachets

Reason for recall

Failed Impurities/Degradation Specification: Out of specification for organic impurities

Recall record

Recall number: D-0339-2024
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide in the USA
Recall initiated: 2024-01-16
Classified by FDA Center: 2024-02-20
FDA published: 2024-02-28
Recalling firm: Ascend Laboratories, LLC
Firm location: Parsippany, NJ

Drug identification

Brand name(s): FOSFOMYCIN TROMETHAMINE
Generic name(s): FOSFOMYCIN TROMETHAMINE
Manufacturer(s): Ascend Laboratories, LLC
NDC(s): 67877-749
Route(s): ORAL

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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