FDAFDA · Food and drugs·Recall number D-1145-2023
Fosfomycin Tromethamine Granules for Oral Solution, 3 g single- dose sachet, Rx only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC# 67877-749-57
Published September 13, 2023 · Recall initiated: July 18, 2023
Status when published: Terminated — 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 Specifications: Out-of-specification results observed for the organic impurities test at 6 months, RT Stability.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- FOSFOMYCIN TROMETHAMINE
- Manufacturer
- Ascend Laboratories, LLC
- Distributor
- The recall product was distributed nationwide.
- UPC
- 0367877749570
- Lot
- Lot #22121970, 22122158, 22121971, 22122189, 22122190, 22122277, 22122278, Exp June 2024; 22122521, 22122522, 22122523, Exp July 2024; 22123328, 22123329, 22123330, Exp September 2024.
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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