Recalls / Class II

Class IID-0617-2017

Product

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

Affected 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

Why it was recalled

Failed Dissolution Specifications; 9 month long term stability

Recalling firm

Firm

Zydus Pharmaceuticals USA Inc

Notification channel

Letter

Type

Voluntary: Firm initiated

Address

73 Route 31 N, Pennington, New Jersey 08534-3601

Distribution

Quantity

32628 bottles

Distribution pattern

Nationwide

Timeline

Recall initiated

2017-03-15

FDA classified

2017-03-27

Posted by FDA

2017-04-05

Terminated

2020-09-10

Status

Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-0617-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.