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Class II: temporary or reversible health riskTerminated

Watson Laboratories, Inc.-(Actavis) - Florida Diclofenac Sodium and Misoprostol Recall

Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75 mg/0

Watson Laboratories, Inc.-(Actavis) - Florida · Davie, FL

Risk level
Class II
Reported by FDA
Feb 19, 2014
Recall ID
D-1082-2014
Check your lot numberHow we source this data

Summary

Watson Laboratories, Inc.-(Actavis) - Florida recalled Diclofenac Sodium and Misoprostol starting Dec 20, 2013. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-1082-2014 on Feb 19, 2014. Reason: Failed Tablet/Capsule Specifications: Split tablets were found in the 12-month stability samples. Status: Terminated.

Why it was recalled

Failed Tablet/Capsule Specifications: Split tablets were found in the 12-month stability samples.

Product description

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.

Lot numbers, UPCs & expiration codes

Lot# 605957A, Exp 09/14

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-1082-2014
Classification
Class II
Status
Terminated
Recall initiated
Dec 20, 2013
FDA report date
Feb 19, 2014
Quantity
5987 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Watson Laboratories, Inc.-(Actavis) - Florida

Original FDA data

Every field from FDA enforcement report D-1082-2014, exactly as published.

Show all FDA fields
City
Davie
State
FL
Status
Terminated
Country
United States
Event ID
67259
Address
4955 Orange Dr
Code information
Lot# 605957A, Exp 09/14
Postal code
33314-3902
Report date
Feb 19, 2014
Product type
Drugs
Recall number
D-1082-2014
Classification
Class II
Recalling firm
Watson Laboratories, Inc.-(Actavis) - Florida
Product quantity
5987 bottles
Termination date
Sep 17, 2014
Reason for recall
Failed Tablet/Capsule Specifications: Split tablets were found in the 12-month stability samples.
Voluntary / mandated
Voluntary: Firm initiated
Product description
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.
Distribution pattern
Nationwide
Recall initiation date
Dec 20, 2013
Initial firm notification
E-Mail
Center classification date
Feb 7, 2014

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1082-2014, published Feb 19, 2014. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

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