Why it was recalled
Failed Tablet/Capsule Specifications: Recall due to complaints of split or broken tablets.
Product description
Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 50 mg/0.2 mg, 60-count bottle, Rx only, Manufactured by: Watson Laboratories, Inc., Corona, CA 92880, NDC 0591-0397-60, UPC 3 05910 39760 9.
Lot numbers, UPCs & expiration codes
Lot #: 660513A, Exp. 10/31/2014
Where it was sold
Nationwide and 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-1617-2014
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Apr 24, 2014
- FDA report date
- Oct 8, 2014
- Quantity
- 6,041 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Actavis Laboratories, FL, Inc.
Original FDA data
Every field from FDA enforcement report D-1617-2014, exactly as published.
Show all FDA fields
- City
- Davie
- State
- FL
- Status
- Terminated
- Country
- United States
- Event ID
- 69237
- Address
- 4955 Orange Dr
- Code information
- Lot #: 660513A, Exp. 10/31/2014
- Postal code
- 33314-3902
- Report date
- Oct 8, 2014
- Product type
- Drugs
- Recall number
- D-1617-2014
- Classification
- Class II
- Recalling firm
- Actavis Laboratories, FL, Inc.
- Product quantity
- 6,041 bottles
- Termination date
- Dec 23, 2016
- Reason for recall
- Failed Tablet/Capsule Specifications: Recall due to complaints of split or broken tablets.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 50 mg/0.2 mg, 60-count bottle, Rx only, Manufactured by: Watson Laboratories, Inc., Corona, CA 92880, NDC 0591-0397-60, UPC 3 05910 39760 9.
- Distribution pattern
- Nationwide and Puerto Rico
- Recall initiation date
- Apr 24, 2014
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Sep 30, 2014