FDA recall D-1617-2014

Product

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.

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-1617-2014