FDAClass IIJune 24, 2015

Divalproex Sodium Extended-Release Tablets recall: Failed Dissolution

Divalproex Sodium Extended-Release Tablets, USP, 500 mg, 100 count bottles, Rx Only, Mfd. By. Dr. Reddy's Laboratories Limited Bachupally 500 090…

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?

Lot #C308195, exp 10/2015

Product
Divalproex Sodium Extended-Release Tablets, USP, 500 mg, 100 count bottles, Rx Only, Mfd. By. Dr. Reddy's Laboratories Limited Bachupally 500 090…
Recalling firm
Dr. Reddy's Laboratories, Inc.
Quantity
5,160 bottles
Distribution
Nationwide
Recall date
June 24, 2015
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls