Recall: D-0264-2021

Class II - Potentially Harmful

Class IIClassification

2021-01-22Initiated

TerminatedStatus

Ascend Laboratories LLCFirm

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

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

Distribution

Nationwide in the USA

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.