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

Recall Number: D-0264-2021

Firm: Ascend Laboratories LLC

Classification: Class II

Status: Terminated

Report Date: 20210224

Initiation Date: 20210122

Termination Date: 20221202

CGMP Deviations: Individual Unidentified impurities results of the product was found at higher side of the specification limit.

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