D-0617-2017 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- April 5, 2017
- Initiation Date
- March 15, 2017
- Termination Date
- September 10, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 32628 bottles
Product 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
Reason for Recall
Failed Dissolution Specifications; 9 month long term stability
Distribution Pattern
Nationwide
Code Information
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