Ascend Laboratories, LLC: Drug Recall
Recall #D-0339-2024 · 01/16/2024
Class II: Risk
Recall Details
- Recall Number
- D-0339-2024
- Classification
- Class II
- Product Type
- Drug
- Recalling Firm
- Ascend Laboratories, LLC
- Status
- Ongoing
- Date Initiated
- 01/16/2024
- Location
- Parsippany, NJ, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 71,244 sachets
Reason for Recall
Failed Impurities/Degradation Specification: Out of specification for organic impurities
Product Description
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
Distribution Pattern
Nationwide in the USA
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.