Why it was recalled
Failed Tablet/Capsule Specifications: Presence of split or broken tablets.
Product description
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.
Lot numbers, UPCs & expiration codes
Lot # 694320A, Expiry: 02/28/2015.
Where it was sold
U.S. Nationwide including Puerto Rico.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0258-2015
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Sep 26, 2014
- FDA report date
- Dec 3, 2014
- Quantity
- 5,451 Bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Actavis Laboratories, FL, Inc.
Original FDA data
Every field from FDA enforcement report D-0258-2015, exactly as published.
Show all FDA fields
- City
- Davie
- State
- FL
- Status
- Terminated
- Country
- United States
- Event ID
- 69495
- Address
- 4955 Orange Dr
- Code information
- Lot # 694320A, Expiry: 02/28/2015.
- Postal code
- 33314-3902
- Report date
- Dec 3, 2014
- Product type
- Drugs
- Recall number
- D-0258-2015
- Classification
- Class II
- Recalling firm
- Actavis Laboratories, FL, Inc.
- Product quantity
- 5,451 Bottles
- Termination date
- Jun 16, 2015
- Reason for recall
- Failed Tablet/Capsule Specifications: Presence of split or broken tablets.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- U.S. Nationwide including Puerto Rico.
- Recall initiation date
- Sep 26, 2014
- Initial firm notification
- Letter
- Center classification date
- Nov 21, 2014