FDAFDA · Food and drugs·Recall number D-0507-2019
Divalproex Sodium Extended-release Tablets, USP 250 mg, 100-count bottle, Rx only, Mfd.By: Dr. Reddy's Laboratories Limited Bachupally - 500 090 India NDC 55111-533-01
Published February 27, 2019 · Recall initiated: January 31, 2019
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: Out of specification results observed for high dissolution.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- DIVALPROEX SODIUM
- Manufacturer
- Dr. Reddy's Laboratories, Inc.
- Distributor
- U.S.A. Nationwide
- Lot
- Lot #: C802676, Exp 03/20
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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