August 2014 FDA Recall Drug by Apotex Corp.
D-1570-2014 - Failed Impurity/Degradation Specification; high out of specification for CAD II degradant
This Class III drug recall was voluntarily initiated by Apotex Corp. on August 21, 2014 for the product Drug. The FDA reported the reason for recall as failed impurity/degradation specification; high out of specification for cad ii degradant. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-1570-2014
Failed Impurity/Degradation Specification; high out of specification for CAD II degradant
08-21-2014
09-24-2014
1,494 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.
Apotex Corp.
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.
Nationwide
10-02-2019
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Candesartan Cilexetil and Hydrochlorothiazide Tablets 32 mg/12.5 mg, 90 count bottles, Rx only, Manufactured by: Apotex Research Pvt. Ltd. Bangalore - 560 099, India NDC 60505-3759-9
Batch or Lot Expiration Information
Lot# KK6086, exp 03/2015, UPC 360505375998.
