Drug recall
Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75mg/0.2mg, 60-count bottle, Rx only, Manufactured…
FDA recall event 65541 · Class II · Watson Laboratories, Inc.-(Actavis) - Florida
Key facts
| Event ID | 65541 |
|---|---|
| Recall numbers | D-817-2013 |
| Recalling firm | Watson Laboratories, Inc.-(Actavis) - Florida |
| Product type | Drugs |
| Products | Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75mg/0.2mg, 60-count bottle, Rx only, Manufactured by Watson Laboratories, Inc., Corona, CA 92880, NDC 0591-0398-60 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Failed Tablet/Capsule Specifications: Broken tablets |
| Initiation date | Mar 22, 2013 |
| Report date | Jul 31, 2013 |
| Termination date | Sep 25, 2014 |
| City | Davie |
| State | FL |
| Country | United States |
| FEI number | 3003194604 |
At a glance
- 1–9 Products in this recall
- 10–99 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: