FDA recall D-1082-2014

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: Split tablets were found in the 12-month stability samples.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2013-12-20

Report date

2014-02-19

Termination date

2014-09-17

Voluntary/Mandated

Voluntary: Firm initiated

Location

Davie, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1082-2014