FDAFDA · Food and drugs·Recall number 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 Laboratories, LLC. Parsippany, NJ 07054. NDC 67877-749-57
Published February 28, 2024 · Recall initiated: January 16, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Impurities/Degradation Specification: Out of specification for organic impurities
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- FOSFOMYCIN TROMETHAMINE
- Manufacturer
- Ascend Laboratories, LLC
- Distributor
- Nationwide in the USA
- UPC
- 0367877749570
- Lot
- 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.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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