FDAFDA · Food and drugs·Recall number D-1616-2014
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.
Published October 8, 2014 · Recall initiated: April 24, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Tablet/Capsule Specifications: Recall due to complaints of split or broken tablets.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Brand
- DICLOFENAC SODIUM AND MISOPROSTOL
- Manufacturer
- Actavis Laboratories, FL, Inc.
- Distributor
- Nationwide and Puerto Rico
- UPC
- 305910398606
- Lot
- Lot #: 605956A, 605958A, Exp. 9/30/2014; 644678M, Exp. 10/31/2014; 661841A, Exp. 11/30/2014; 717469A, Exp 2/28/2015
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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