Recalls / Class II
Class IID-1616-2014
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 #: 605956A, 605958A, Exp. 9/30/2014; 644678M, Exp. 10/31/2014; 661841A, Exp. 11/30/2014; 717469A, Exp 2/28/2015
Why it was recalled
Failed Tablet/Capsule Specifications: Recall due to complaints of split or broken tablets.
Recalling firm
- Firm
- Actavis Laboratories, FL, Inc.
- Manufacturer
- Actavis Pharma, Inc.
- Notification channel
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Type
- Voluntary: Firm initiated
- Address
- 4955 Orange Dr, N/A, Davie, Florida 33314-3902
Distribution
- Quantity
- 36,538 bottles
- Distribution pattern
- Nationwide and Puerto Rico
Timeline
- Recall initiated
- 2014-04-24
- FDA classified
- 2014-09-30
- Posted by FDA
- 2014-10-08
- Terminated
- 2016-12-23
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1616-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.