March 2017 FDA Recall Drug by Zydus Pharmaceuticals Usa Inc
D-0617-2017 - Failed Dissolution Specifications; 9 month long term stability

This Class II drug recall was voluntarily initiated by Zydus Pharmaceuticals Usa Inc on March 15, 2017 for the product Drug. The FDA reported the reason for recall as failed dissolution specifications; 9 month long term stability. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0617-2017

Reason for Recall
Failed Dissolution Specifications; 9 month long term stability
Initiated
03-15-2017
Reported
04-05-2017
Quantity
32628 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
76737
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Zydus Pharmaceuticals USA Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-10-2020
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

Lot# 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