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.

FDA recall notice · announced December 3, 2014 · Actavis Laboratories, Fl

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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: Presence of split or broken tablets.

Notes

Distribution: U.S. Nationwide including Puerto Rico.
Lot/code information: Lot # 694320A, Expiry: 02/28/2015.
Quantity: 5,451 Bottles
Status: Terminated
Products in this recall event:
- 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. (D-0258-2015)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.