FDAClass IIJune 24, 2015

Divalproex Sodium Extended-Release Tablets recall: Failed Dissolution

Divalproex Sodium Extended-Release Tablets, USP, (valproic acid activity), 250 mg, 100 count (NDC 55111-533-01) and 500 count (NDC 55111-533-05)…

Why was Divalproex Sodium Extended-Release Tablets recalled?

Failed Dissolution Specifications; exceeded specification at the 9 hour time point

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?

100 count bottle - Lot #C307859, exp 09/2015; 500 count bottle - Lot #C307859 and Lot# C307812, exp 09/2015

Product
Divalproex Sodium Extended-Release Tablets, USP, (valproic acid activity), 250 mg, 100 count (NDC 55111-533-01) and 500 count (NDC 55111-533-05)…
Recalling firm
Dr. Reddy's Laboratories, Inc.
Quantity
100 count 7479; 500 count - 2544
Distribution
Nationwide
Recall date
June 24, 2015
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls