Divalproex Sodium Extended Release Tablets recall: Failed Dissolution
Divalproex Sodium Extended Release Tablets, USP, 250 mg, packaged in 100-count bottle, Rx only, Manufactured by: Amneal Pharmaceuticals, India, Distributed by: Amneal Pharmaceuticals, Bridgewater, NJ, NDC 65162-755-10
Why was Divalproex Sodium Extended Release Tablets recalled?
Failed dissolution specifications.
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 #: AR210705, Exp 04/2024
- Product
- Divalproex Sodium Extended Release Tablets, USP, 250 mg, packaged in 100-count bottle, Rx only, Manufactured by: Amneal Pharmaceuticals, India, Distributed by: Amneal Pharmaceuticals, Bridgewater, NJ, NDC 65162-755-10
- Recalling firm
- Amneal Pharmaceuticals of New York, LLC
- Quantity
- 4,309 bottles
- Distribution
- USA nationwide
- Recall date
- August 31, 2022
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)