Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 50 mg/0.2 mg, 60-count bottle, Rx only, Manufactured by: Watson Laboratories, Inc., Corona, CA 92880, NDC 0591-0397-60, UPC 3 05910 39760 9.
Reported: October 8, 2014 Initiated: April 24, 2014 #D-1617-2014
Product Description
Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 50 mg/0.2 mg, 60-count bottle, Rx only, Manufactured by: Watson Laboratories, Inc., Corona, CA 92880, NDC 0591-0397-60, UPC 3 05910 39760 9.
Reason for Recall
Failed Tablet/Capsule Specifications: Recall due to complaints of split or broken tablets.
Details
- Recalling Firm
- Actavis Laboratories, FL, Inc.
- Units Affected
- 6,041 bottles
- Distribution
- Nationwide and Puerto Rico
- Location
- Davie, FL
Frequently Asked Questions
What product was recalled? ▼
Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 50 mg/0.2 mg, 60-count bottle, Rx only, Manufactured by: Watson Laboratories, Inc., Corona, CA 92880, NDC 0591-0397-60, UPC 3 05910 39760 9.. Recalled by Actavis Laboratories, FL, Inc.. Units affected: 6,041 bottles.
Why was this product recalled? ▼
Failed Tablet/Capsule Specifications: Recall due to complaints of split or broken tablets.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on October 8, 2014. Severity: Moderate. Recall number: D-1617-2014.
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