FDAFDA · Food and drugs·Recall number D-1362-2022
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
Published August 31, 2022 · Recall initiated: July 27, 2022
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed dissolution specifications.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- DIVALPROEX SODIUM
- Manufacturer
- Amneal Pharmaceuticals of New York, LLC
- Distributor
- USA nationwide
- UPC
- 0365162755107
- Lot
- Lot #: AR210705, Exp 04/2024
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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