Class II
Terminated
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
- Company
- Zydus Pharmaceuticals (Usa) Inc
- Recall Initiated
- March 15, 2017
- Posted
- April 5, 2017
- Recall Number
- D-0617-2017
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 32628 bottles
- Firm Location
- Pennington, NJ, United States
Reason for Recall
Failed Dissolution Specifications; 9 month long term stability
Distribution
Nationwide
Lot / Code Info
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
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