Recalls / Class III
Class IIID-1145-2023
Product
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
- Brand name
- Fosfomycin Tromethamine
- Generic name
- Fosfomycin Tromethamine
- Active ingredient
- Fosfomycin Tromethamine
- Route
- Oral
- NDC
- 67877-749
- FDA application
- ANDA214554
- Affected lot / code info
- Lot #22121970, 22122158, 22121971, 22122189, 22122190, 22122277, 22122278, Exp June 2024; 22122521, 22122522, 22122523, Exp July 2024; 22123328, 22123329, 22123330, Exp September 2024.
Why it was recalled
Failed Impurities/Degradation Specifications: Out-of-specification results observed for the organic impurities test at 6 months, RT Stability.
Recalling firm
- Firm
- Ascend Laboratories, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 339 Jefferson Rd Ste 101, N/A, Parsippany, New Jersey 07054-3707
Distribution
- Quantity
- 99,516 sachets
- Distribution pattern
- The recall product was distributed nationwide.
Timeline
- Recall initiated
- 2023-07-18
- FDA classified
- 2023-09-06
- Posted by FDA
- 2023-09-13
- Terminated
- 2026-02-19
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1145-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.