FDA recall D-0829-2021

Product

Zonisamide 100 mg Capsules, 30-count bottles, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg. For Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, NDC 61919-0775-30

Reason for recall

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

Distribution

FL only

Key facts

Status

Terminated

Initiation date

2021-09-14

Report date

2021-09-29

Termination date

2021-10-22

Voluntary/Mandated

Voluntary: Firm initiated

Location

Dawsonville, GA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0829-2021