FDA Recall Diclofenac Sodium And Misoprostol
View Recall Number, Date, Reasons, Quantity
FDA Recall Enforcement Reports
The most recent Recall Enforcement Report that covers this product was initiated on September 26th, 2014 and classified as a Class II recall due to failed tablet/capsule specifications: presence of split or broken tablets. This recall is currently terminated, and the associated recall number is recall number is D-0258-2015. It pertains to Diclofenac Sodium And Misoprostol identified by 0591-0397 as of 06-16-2015 .
| Recall Number | Recall Initiation Date | Report Date | Quantity | Product Description | Recall Reason | Status |
|---|---|---|---|---|---|---|
| D-0258-2015 | 09-26-2014 | 12-03-2014 | 5,451 Bottles | 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. | Failed Tablet/Capsule Specifications: Presence of split or broken tablets. | Terminated |
| D-1617-2014 | 04-24-2014 | 10-08-2014 | 6,041 bottles | 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. | Failed Tablet/Capsule Specifications: Recall due to complaints of split or broken tablets. | Terminated |
| D-1616-2014 | 04-24-2014 | 10-08-2014 | 36,538 bottles | 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. | Failed Tablet/Capsule Specifications: Recall due to complaints of split or broken tablets. | Terminated |
| D-1082-2014 | 12-20-2013 | 02-19-2014 | 5987 bottles | 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. | Failed Tablet/Capsule Specifications: Split tablets were found in the 12-month stability samples. | Terminated |
| D-1060-2014 | 03-22-2013 | 02-12-2014 | 6,540 bottles | 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) | Failed Tablet/Capsule Specifications: Broken tablets | Terminated |
| D-817-2013 | 03-22-2013 | 07-31-2013 | 392,400 tablets | 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 | Failed Tablet/Capsule Specifications: Broken tablets | Terminated |
What is a Recall Enforcement Report?
A Recall Enforcement Report is an official publication by the FDA that documents all classified drug recalls.
When a company initiates a product removal or correction, the FDA evaluates whether the action meets the criteria for a recall. If it does, the FDA assesses the level of public health risk and assigns a recall classification (Class I, II, or III). Once classified, the recall is published in the Enforcement Report, which includes details such as the product name, affected lot numbers, reason for recall, and scope of distribution.
The Enforcement Report ensures transparency and allows the public and healthcare professionals to stay informed about products that may present a health or safety concern.
Understanding Recall Reports
The recall information provided on this website is sourced directly from official U.S. Food and Drug Administration (FDA) data. It is important to understand that most product recalls are limited in scope and typically involve only specific lots or batches of a product that have been identified as potentially defective or non-compliant with regulatory standards.
Recalls may be initiated voluntarily by the manufacturer or distributor, or they may be mandated by the FDA when a product is found to pose a health risk. A recall does not necessarily mean that all units of a product are unsafe.
If you have concerns about the safety of a medication or healthcare product you are using, it is strongly recommended that you verify the product’s lot number and consult your pharmacist or healthcare provider to determine whether your specific product is affected by the recall.
