FDA recall D-0888-2022

Product

Zonisamide Capsules USP, 100 mg, 90-count bottle, Rx Only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, NDC 61919-775-90

Reason for recall

CGMP Deviations: Gaps in the quality system in the Quality Control microbiology laboratory.

Distribution

Nationwide to the U.S. market

Key facts

Status

Terminated

Initiation date

2022-05-13

Report date

2022-06-01

Termination date

2024-09-30

Voluntary/Mandated

Voluntary: Firm initiated

Location

Dawsonville, GA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0888-2022