Ascend Laboratories LLC recalls Cephalexin for Oral Suspension, USP 250 mg per 5 mL 200 ml (when mixed) Rx Only, Manufactured by: Alkem Laboratories, Lt
Recalled February 24, 2021 · FDA recall D-0264-2021 · Ascend Laboratories
Hazard
CGMP Deviations: Individual Unidentified impurities results of the product was found at higher side of the specification limit. · FDA Class II
Units
23,436 200 mL bottles
Sold at
Nationwide in the USA
Description
CGMP Deviations: Individual Unidentified impurities results of the product was found at higher side of the specification limit.
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
Manufacturer(s)
Ascend Laboratories LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →