Drug recall D-0263-2021
Product
Cephalexin for Oral Suspension, USP 250 mg per 5 mL, 100 ml (when mixed) Rx Only, Manufactured by: Alkem Laboratories, Ltd, Mumbai -400 013 INDIA Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054 NDC 67877-545-88
Reason for recall
CGMP Deviations: Individual Unidentified impurities results of the product was found at higher side of the specification limit.
Lots and codes
Lot # 19144841, Exp 9/2021; 20141673 Exp 4/2022.
Recall details
- Recalling firm
- Ascend Laboratories LLC, Parsippany, NJ
- Quantity
- 14,205 100 mL bottles
- Distribution
- Nationwide in the USA
- Type
- Voluntary: Firm initiated
- Recall initiated
- January 22, 2021
- Terminated
- December 2, 2022
Related products
- Cephalexin – drug information
- NDC 67877-544 Cephalexin · Cephalexin 125 mg/5mL · Ascend Laboratories, LLC
- NDC 67877-545 Cephalexin · Cephalexin 250 mg/5mL · Ascend Laboratories, LLC