Divalproex Sodium Extended-Release Tablets recall: CGMP Deviations
Divalproex Sodium Extended-Release Tablets, USP, 250 mg a) 100-count bottle (NDC 55111-0533-01), b) 500-count bottle (NDC 55111-0533-05), Rx only…
Why was Divalproex Sodium Extended-Release Tablets recalled?
cGMP deviations: Product was exposed above 50% relative humidity levels during packaging operations.
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 #: a) C802629, Exp. 03/2020; C805680, Exp. 07/2020, C808821,Exp. 10/2020; b) C806561, Exp. 10/2020
- Product
- Divalproex Sodium Extended-Release Tablets, USP, 250 mg a) 100-count bottle (NDC 55111-0533-01), b) 500-count bottle (NDC 55111-0533-05), Rx only…
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
- Quantity
- 33,958 bottles
- Distribution
- Product was distributed to major distributors and retailers who may have further distribute the product throughout the United States.
- Recall date
- April 24, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)