Recall: D-0339-2024

Class II - Potentially Harmful

Class IIClassification

2024-01-16Initiated

OngoingStatus

Ascend Laboratories, LLCFirm

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

Distribution

Nationwide in the USA

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.