FDA recall D-0258-2015

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.

Distribution

U.S. Nationwide including Puerto Rico.

Key facts

Status

Terminated

Initiation date

2014-09-26

Report date

2014-12-03

Termination date

2015-06-16

Voluntary/Mandated

Voluntary: Firm initiated

Location

Davie, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0258-2015