FDARecalled Feb 28, 2024 · #D-0339-2024
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 Labor...
Hazard
Class II — temporary health risk
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Failed Impurities/Degradation Specification: Out of specification for organic impurities Classification: Class II Distribution: Nationwide in the USA
Product details
- 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
- Type
- Drugs
- Manufacturer
- Ascend Laboratories, LLC
- Model numbers
- —
- UPCs
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