Drug recall
Zonisamide 100 mg Capsules, 30-count bottles, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534…
FDA recall event 88749 · Class II · Direct Rx
Key facts
| Event ID | 88749 |
|---|---|
| Recall numbers | D-0829-2021 |
| Recalling firm | Direct Rx |
| Product type | Drugs |
| Products | 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 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | CGMP deviations: Gaps in the quality system in the Quality Control microbiology laboratory. |
| Initiation date | Sep 14, 2021 |
| Report date | Sep 29, 2021 |
| Termination date | Oct 22, 2021 |
| City | Dawsonville |
| State | GA |
| Country | United States |
| FEI number | 3011690045 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: