FDA recall D-1060-2014

Product

Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75mg/0.2mg, Rx only, Manufactured by Watson Laboratories, Inc., Corona, CA 92880, NDC 0591-0398-60 (60 count bottles)

Reason for recall

Failed Tablet/Capsule Specifications: Broken tablets

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2013-03-22

Report date

2014-02-12

Termination date

2015-02-26

Voluntary/Mandated

Voluntary: Firm initiated

Location

Parsippany, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1060-2014