Divalproex Sodium Extended-release Tablets recall: CGMP Deviations
DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS, USP Tablets, 250 mg, 100 count-unit dose carton, RX only, Manufactured by Dr. Reddy's Laboratories Ltd. Bachupally - 500 090 India. Distributed by: Major Pharmaceuticals 17177 N Laurel Park Dr., Suite 233 Livonia, MI 48152. NDC # 0904-6363-61.
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# M02250 EXP 10/2020.
- Product
- DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS, USP Tablets, 250 mg, 100 count-unit dose carton, RX only, Manufactured by Dr. Reddy's Laboratories Ltd. Bachupally - 500 090 India. Distributed by: Major Pharmaceuticals 17177 N Laurel Park Dr., Suite 233 Livonia, MI 48152. NDC # 0904-6363-61.
- Recalling firm
- MAJOR PHARMACEUTICALS
- Quantity
- 828 100-count unit dose cartons
- Distribution
- Nationwide in the USA
- Recall date
- August 7, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)