Class II

Drug Recall: 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 Laborato

Ascend Laboratories, LLC · January 16, 2024

Reason for Recall

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

Product Description

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

Distribution

Nationwide in the USA

States Affected

NATIONWIDE

Quantity Affected

71,244 sachets

Source: FDA (openFDA Drug Enforcement)

Recall number: D-0339-2024

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.