Divalproex Sodium Delayed Release Tablets, USP, 500 mg, a) 100 count (NDC 68382-033-01) and b) 500 count (NDC 68382-033-05) bottles, Rx only, manufactured by Cadila Healthcare Ltd, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals, Pennington, NJ
Class I - DangerousWhat Should You Do?
- Check if you have this product: a) MR8221, MR8222 exp 7/31/2017; MR10260, exp 9/30/2017; MR10926, exp 10/31/2017; b) MR6187, exp 5/31/2017; MR7302, exp 6/30/2017; MR7768, MR7769, exp 7/31/2017; MR8247, exp 7/31/2017; MR8887, MR8892, MR8893 exp 8/31/2017; MR9014, MR10414 exp 9/30/2017; MR10928, exp 10/31/2017; MR11183, MR11185, MR11186, exp 11/30/2017
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Zydus Pharmaceuticals USA Inc
- Reason for Recall:
- Failed Dissolution Specifications; 9 month long term stability
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Divalproex Sodium Delayed Release Tablets, USP, 500 mg, a) 100 count (NDC 68382-033-01) and b) 500 count (NDC 68382-033-05) bottles, Rx only, manufactured by Cadila Healthcare Ltd, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals, Pennington, NJ
Product Codes/Lot Numbers:
a) MR8221, MR8222 exp 7/31/2017; MR10260, exp 9/30/2017; MR10926, exp 10/31/2017; b) MR6187, exp 5/31/2017; MR7302, exp 6/30/2017; MR7768, MR7769, exp 7/31/2017; MR8247, exp 7/31/2017; MR8887, MR8892, MR8893 exp 8/31/2017; MR9014, MR10414 exp 9/30/2017; MR10928, exp 10/31/2017; MR11183, MR11185, MR11186, exp 11/30/2017
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: D-0617-2017
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Zydus Pharmaceuticals (USA)
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