Ascend Laboratories, LLC: Drug Recall
Recall #D-1145-2023 · 07/18/2023
Class III: Low Risk
Recall Details
- Recall Number
- D-1145-2023
- Classification
- Class III
- Product Type
- Drug
- Recalling Firm
- Ascend Laboratories, LLC
- Status
- Completed
- Date Initiated
- 07/18/2023
- Location
- Parsippany, NJ, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 99,516 sachets
Reason for Recall
Failed Impurities/Degradation Specifications: Out-of-specification results observed for the organic impurities test at 6 months, RT Stability.
Product Description
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
Distribution Pattern
The recall product was distributed nationwide.
Other Recalls by Ascend Laboratories, LLC
- Class II: Risk 09/19/2025
- Class II: Risk 09/19/2025
- Class II: Risk 09/19/2025
- Class II: Risk 09/19/2025
- Class II: Risk 08/28/2025
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.