Recalls / Class II
Class IID-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)
- Brand name
- Diclofenac Sodium And Misoprostol
- Generic name
- Diclofenac Sodium And Misoprostol
- Active ingredients
- Diclofenac Sodium, Misoprostol
- Route
- Oral
- NDCs
- 0591-0397, 0591-0398
- FDA application
- ANDA201089
- Affected lot / code info
- Lot 668271A, Exp 11/14 and Lot 684119A Exp 01/2015
Why it was recalled
Failed Tablet/Capsule Specifications: Broken tablets
Recalling firm
- Firm
- Actavis Inc
- Manufacturer
- Actavis Pharma, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 400 Interpace Pkwy, Parsippany, New Jersey 07054-1120
Distribution
- Quantity
- 6,540 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2013-03-22
- FDA classified
- 2014-02-03
- Posted by FDA
- 2014-02-12
- Terminated
- 2015-02-26
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1060-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.