FDAFDA · Food and drugs·Recall number D-1133-2019
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, Mfd. By: Dr. Reddy's Laboratories Limited, Bachupally, - 500 090 INDIA
Published April 24, 2019 · Recall initiated: April 11, 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
cGMP deviations: Product was exposed above 50% relative humidity levels during packaging operations.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Dr. Reddy's Laboratories, Inc.
- Distributor
- Product was distributed to major distributors and retailers who may have further distribute the product throughout the United States.
- Lot
- Lot #: a) C802629, Exp. 03/2020; C805680, Exp. 07/2020, C808821,Exp. 10/2020; b) C806561, Exp. 10/2020
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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