FDA recall D-0793-2022

Glenmark Pharmaceuticals Inc., USA · Class II · drug

Product

Zonisamide Capsules, USP, 100 mg, packaged in: a) 100-count bottle (NDC 68462-130-01); b) 500-count bottle (NDC 68462-130-05), Rx only, Manufactured by: Glenmark Pharmaceuticals, Inc., USA Monroe, NC 28110, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430

Reason for recall

cGMP deviations

Distribution

USA nationwide

Key facts

Status: Completed
Initiation date: 2022-04-25
Report date: 2022-05-04
Voluntary/Mandated: Voluntary: Firm initiated
Location: Mahwah, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0793-2022