FDA 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.

Distribution

Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2021-01-22

Report date

2021-02-24

Termination date

2022-12-02

Voluntary/Mandated

Voluntary: Firm initiated

Location

Parsippany, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0263-2021