FDAClass IIIJanuary 23, 2013

Divalproex Sodium Delayed-Release Tablets recall: Labeling Error

Divalproex Sodium Delayed-Release Tablets, USP, 500 mg Valproic Acid Activity, 100-count tablets per bottle, Rx only, Manufactured by Upsher-Smith…

Why was Divalproex Sodium Delayed-Release Tablets recalled?

Labeling: Label Error On Declared Strength; Some bottles of product were missing the color-coded strength on the primary display panel of the label.

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 #: 310162, Exp 09/14

Product
Divalproex Sodium Delayed-Release Tablets, USP, 500 mg Valproic Acid Activity, 100-count tablets per bottle, Rx only, Manufactured by Upsher-Smith…
Recalling firm
Upsher Smith Laboratories, Inc.
Quantity
11,316 bottles
Distribution
Nationwide and Puerto Rico
Recall date
January 23, 2013
Classification
Class III
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls