FDA-Drug2024-02-28Class II
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
Ascend Laboratories, LLC
Hazard
Failed Impurities/Degradation Specification: Out of specification for organic impurities
Sold states
Nationwide in the USA
Affected count
71,244 sachets
Manufactured in
339 Jefferson Rd Ste 101, N/A, Parsippany, NJ, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0339-2024Don't want to check this manually?
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