# FDA recall D-817-2013

> **Watson Laboratories, Inc.-(Actavis) - Florida** · Class II · drug recall initiated 2013-03-22.

## Product

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

## Reason for recall

Failed Tablet/Capsule Specifications: Broken tablets

## Distribution

Nationwide

## Key facts

- **Recall number:** D-817-2013
- **Recalling firm:** Watson Laboratories, Inc.-(Actavis) - Florida
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2013-03-22
- **Report date:** 2013-07-31
- **Termination date:** 2014-09-25

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Davie, FL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-817-2013

## Citation

> AI Analytics. FDA recall D-817-2013. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-817-2013. Source: US FDA. Licensed CC0.

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