FDA recall D-1616-2014

Actavis Laboratories, FL, Inc. · Class II · drug

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

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

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1616-2014