Drug recall
TOPIRAMATE Tablets 200 mg, 60 Tablet Bottles, Rx Only. Manufactured by Cadila Healthcare Ltd. Ahmedabad, India…
FDA recall event 69387 · Class II · Zydus Pharmaceuticals USA Inc
Key facts
| Event ID | 69387 |
|---|---|
| Recall numbers | D-0015-2015 |
| Recalling firm | Zydus Pharmaceuticals USA Inc |
| Product type | Drugs |
| Products | TOPIRAMATE Tablets 200 mg, 60 Tablet Bottles, Rx Only. Manufactured by Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ USA 08534. NDC… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Presence of Foreign Tablets: Presence of topiramate 100 mg tablets comingled with 200 mg tablets. |
| Initiation date | Sep 15, 2014 |
| Report date | Oct 22, 2014 |
| Termination date | Sep 20, 2017 |
| City | Pennington |
| State | NJ |
| Country | United States |
| FEI number | 3008444937 |
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: