Why it was recalled
Failed Tablet/Capsule Specifications: Broken tablets
Product description
Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75mg/0.2mg, Rx only, Manufactured by Watson Laboratories, Inc., Corona, CA 92880, NDC 0591-0398-60 (60 count bottles)
Lot numbers, UPCs & expiration codes
Lot 668271A, Exp 11/14 and Lot 684119A Exp 01/2015
Where it was sold
Nationwide
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-1060-2014
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 22, 2013
- FDA report date
- Feb 12, 2014
- Quantity
- 6,540 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Actavis Inc
Original FDA data
Every field from FDA enforcement report D-1060-2014, exactly as published.
Show all FDA fields
- City
- Parsippany
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 66380
- Address
- 400 Interpace Pkwy
- Code information
- Lot 668271A, Exp 11/14 and Lot 684119A Exp 01/2015
- Postal code
- 07054-1120
- Report date
- Feb 12, 2014
- Product type
- Drugs
- Recall number
- D-1060-2014
- Classification
- Class II
- Recalling firm
- Actavis Inc
- Product quantity
- 6,540 bottles
- Termination date
- Feb 26, 2015
- Reason for recall
- Failed Tablet/Capsule Specifications: Broken tablets
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75mg/0.2mg, Rx only, Manufactured by Watson Laboratories, Inc., Corona, CA 92880, NDC 0591-0398-60 (60 count bottles)
- Distribution pattern
- Nationwide
- Recall initiation date
- Mar 22, 2013
- Initial firm notification
- Letter
- Center classification date
- Feb 3, 2014