FDAClass IIJuly 31, 2013

Diclofenac Sodium and Misoprostol Delayed-Release recall

Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75mg/0.2mg, 60-count bottle, Rx only, Manufactured by Watson Laboratories, Inc., Corona, CA…

Why was Diclofenac Sodium and Misoprostol Delayed-Release recalled?

Failed Tablet/Capsule Specifications: Broken tablets

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot 635098A, Exp 10/14

Product
Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75mg/0.2mg, 60-count bottle, Rx only, Manufactured by Watson Laboratories, Inc., Corona, CA…
Recalling firm
Watson Laboratories, Inc.-(Actavis) - Florida
Quantity
392,400 tablets
Distribution
Nationwide
Recall date
July 31, 2013
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls