January 2016 FDA Recall Drug by Zydus Pharmaceuticals Usa Inc
D-0725-2016 - Failed Impurities/Degradation Specifications
This Class III drug recall was voluntarily initiated by Zydus Pharmaceuticals Usa Inc on January 14, 2016 for the product Drug. The FDA reported the reason for recall as failed impurities/degradation specifications. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0725-2016
Failed Impurities/Degradation Specifications: Out of specification for a known degradant.
01-14-2016
03-02-2016
9504 Bottles
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
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.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
US Nationwide including Puerto Rico
12-18-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
risperiDONE ORALLY DISINTEGRATING TABLETS, 2 mg, 30 Ct Bottles, Rx Only. Manufactured by: Cadila Healthcare Ltd., Ahmedabad, India. Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534. NDC: 68382-156-06.
Batch or Lot Expiration Information
Lot# : MP4967, Expiry: 04/2016.
