# FDA recall D-1616-2014

> **Actavis Laboratories, FL, Inc.** · Class II · drug recall initiated 2014-04-24.

## Product

Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75 mg/0.2 mg, 60-count bottle, Rx only, Manufactured by: Watson Laboratories, Inc., Corona, CA 92880, NDC 0591-0398-60, UPC 3 05910 39860 6.

## Reason for recall

Failed Tablet/Capsule Specifications: Recall due to complaints of split or broken tablets.

## Distribution

Nationwide and Puerto Rico

## Key facts

- **Recall number:** D-1616-2014
- **Recalling firm:** Actavis Laboratories, FL, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2014-04-24
- **Report date:** 2014-10-08
- **Termination date:** 2016-12-23

- **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-1616-2014

## Citation

> AI Analytics. FDA recall D-1616-2014. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/D-1616-2014. Source: US FDA. Licensed CC0.

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