Ascend Laboratories LLC: Drug Recall
Recall #D-0264-2021 · 01/22/2021
Class II: Risk
Recall Details
- Recall Number
- D-0264-2021
- Classification
- Class II
- Product Type
- Drug
- Recalling Firm
- Ascend Laboratories LLC
- Status
- Terminated
- Date Initiated
- 01/22/2021
- Location
- Parsippany, NJ, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 23,436 200 mL bottles
Reason for Recall
CGMP Deviations: Individual Unidentified impurities results of the product was found at higher side of the specification limit.
Product Description
Cephalexin for Oral Suspension, USP 250 mg per 5 mL 200 ml (when mixed) Rx Only, Manufactured by: Alkem Laboratories, Ltd, Mumbai -400 013 INDIA Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054 NDC 67877-545-68
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.