Product: 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
Reason for recall: CGMP Deviations: Individual Unidentified impurities results of the product was found at higher side of the specification limit.
Recall initiated: 20210122
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated