FDAFDA · Food and drugs·Recall number D-1291-2022
Divalproex Sodium Delayed-Release Tablets, USP 500mg, Rx Only, 100 Tablets, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries, Ltd., Halol-Baroda Highway, Halol- 389 350, Gujarat, India, NDC 62756-798-88.
Published August 3, 2022 · Recall initiated: June 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: Failure occurred during routine stability testing of dissolution test.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- DIVALPROEX SODIUM
- Manufacturer
- SUN PHARMACEUTICAL INDUSTRIES INC
- Distributor
- Nationwide in the USA
- UPC
- 0362756796836
- Lot
- Lot: HAC1312A, EXP. 05/2024
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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