FDA Drug recall D-0888-2022
Zonisamide Capsules USP, 100 mg, 90-count bottle, Rx Only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534, Manufactured for:…
- FDA Drug
- Class II
- terminated
- Published 2022-06-01
On 2022-06-01 the FDA classified a Class II recall of Zonisamide Capsules USP, 100 mg, 90-count bottle, Rx Only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534, Manufactured for:… 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-0888-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-05-13 |
| Published | 2022-06-01 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Direct Rx |
| Distribution | US |
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
CGMP Deviations: Gaps in the quality system in the Quality Control microbiology laboratory.
Identifiers
| code_info | Lot: 23JY2124 Exp. 6/30/23 |
|---|
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-0888-2022%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.