Why it was recalled
Failed Tablet/Capsule Specifications: Broken tablets
Product description
Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75mg/0.2mg, 60-count bottle, Rx only, Manufactured by Watson Laboratories, Inc., Corona, CA 92880, NDC 0591-0398-60
Lot numbers, UPCs & expiration codes
Lot 635098A, Exp 10/14
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-817-2013
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 22, 2013
- FDA report date
- Jul 31, 2013
- Quantity
- 392,400 tablets
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Watson Laboratories, Inc.-(Actavis) - Florida
Original FDA data
Every field from FDA enforcement report D-817-2013, exactly as published.
Show all FDA fields
- City
- Davie
- State
- FL
- Status
- Terminated
- Country
- United States
- Event ID
- 65541
- Address
- 4955 Orange Dr
- Code information
- Lot 635098A, Exp 10/14
- Postal code
- 33314-3902
- Report date
- Jul 31, 2013
- Product type
- Drugs
- Recall number
- D-817-2013
- Classification
- Class II
- Recalling firm
- Watson Laboratories, Inc.-(Actavis) - Florida
- Product quantity
- 392,400 tablets
- Termination date
- Sep 25, 2014
- 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, 60-count bottle, Rx only, Manufactured by Watson Laboratories, Inc., Corona, CA 92880, NDC 0591-0398-60
- Distribution pattern
- Nationwide
- Recall initiation date
- Mar 22, 2013
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Jul 23, 2013