Recalls / Class II
Class IID-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.
- 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 # 694320A, Expiry: 02/28/2015.
Why it was recalled
Failed Tablet/Capsule Specifications: Presence of split or broken tablets.
Recalling firm
- Firm
- Actavis Laboratories, FL, Inc.
- Manufacturer
- Actavis Pharma, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 4955 Orange Dr, N/A, Davie, Florida 33314-3902
Distribution
- Quantity
- 5,451 Bottles
- Distribution pattern
- U.S. Nationwide including Puerto Rico.
Timeline
- Recall initiated
- 2014-09-26
- FDA classified
- 2014-11-21
- Posted by FDA
- 2014-12-03
- Terminated
- 2015-06-16
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0258-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.