FDA Drug recall D-0829-2021
Zonisamide 100 mg Capsules, 30-count bottles, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg
- FDA Drug
- Class II
- terminated
- Published 2021-09-29
On 2021-09-29 the FDA classified a Class II recall of Zonisamide 100 mg Capsules, 30-count bottles, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg by Direct Rx, citing CGMP deviations: Gaps in the quality system in the Quality Control microbiology laboratory.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0829-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-09-14 |
| Published | 2021-09-29 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Direct Rx |
| Distribution | FL |
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
CGMP deviations: Gaps in the quality system in the Quality Control microbiology laboratory.
Identifiers
| code_info | Lot #: 17JU2118 Exp. 5/31/23 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0829-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.