Recalls / Class II
Class IID-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.
- 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# 605957A, Exp 09/14
Why it was recalled
Failed Tablet/Capsule Specifications: Split tablets were found in the 12-month stability samples.
Recalling firm
- Firm
- Watson Laboratories, Inc.-(Actavis) - Florida
- Manufacturer
- Actavis Pharma, Inc.
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 4955 Orange Dr, N/A, Davie, Florida 33314-3902
Distribution
- Quantity
- 5987 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2013-12-20
- FDA classified
- 2014-02-07
- Posted by FDA
- 2014-02-19
- Terminated
- 2014-09-17
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1082-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.