FDA recall D-0185-2021

Product

Cephalexin for Oral Suspension, USP, 125 mg per 5 mL, packaged as a) 100 ml (when mixed) bottle, NDC 67877-544-88; b) 200 ml (when mixed) bottle NDC 67877-544-68, Rx Only, Manufactured by: Alkem Laboratories, Ltd, Mumbai -400 013 INDIA. Distributed by: Ascend Lab,oratories, LLC Parsippany, NJ 07054

Reason for recall

Failed Impurity/Degradation Specifications: Unidentified impurities not complying with specifications were observed in various lots of Cephalexin FOS USP 125 mg/5 mL.

Distribution

Distributed Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2020-11-23

Report date

2021-01-13

Termination date

2023-06-01

Voluntary/Mandated

Voluntary: Firm initiated

Location

Parsippany, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0185-2021