FDA recall D-0822-2021

Glenmark Pharmaceuticals Inc., USA · Class II · drug

Product

Naproxen Sodium Tablets, USP 550 mg Rx Only Manufactured by: Glenmark Pharmaceuticals Inc., USA 4147 Goldmine Road Monroe, NC 28110 Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 a) 100 Tablets NDC 68462-179-01; b) 500 Tablets NDC 68462-179-05

Reason for recall

CGMP Deviations

Distribution

Nationwide.

Key facts

Status: Terminated
Initiation date: 2021-08-27
Report date: 2021-09-29
Termination date: 2023-10-04
Voluntary/Mandated: Voluntary: Firm initiated
Location: Mahwah, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0822-2021