FDA recall D-817-2013
Watson Laboratories, Inc.-(Actavis) - Florida · Class II · drug
Product
Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75mg/0.2mg, 60-count bottle, Rx only, Manufactured by Watson Laboratories, Inc., Corona, CA 92880, NDC 0591-0398-60
Reason for recall
Failed Tablet/Capsule Specifications: Broken tablets
Distribution
Nationwide
Key facts
- Status
- Terminated
- Initiation date
- 2013-03-22
- Report date
- 2013-07-31
- Termination date
- 2014-09-25
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Davie, FL, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-817-2013