FDA recall D-0179-2021

Product

Ascend Laboratories, llc 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

Failed Impurity/Degradation Specifications

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2020-12-17

Report date

2021-01-06

Termination date

2023-05-03

Voluntary/Mandated

Voluntary: Firm initiated

Location

Parsippany, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0179-2021