December 2015 FDA Recall Drug by Sandoz Inc
D-0659-2016 - Failed Impurities/Degradation Specifications; 9 month stability timepoint

This Class III drug recall was voluntarily initiated by Sandoz Inc on December 31, 2015 for the product Drug. The FDA reported the reason for recall as failed impurities/degradation specifications; 9 month stability timepoint. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0659-2016

Reason for Recall
Failed Impurities/Degradation Specifications; 9 month stability timepoint
Initiated
12-31-2015
Reported
02-17-2016
Quantity
277,267 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73035
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Sandoz 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.
04-12-2017
Product Description About Product Description
Full technical description of the product.
Candesartan Cilexetil Tablets, 16 mg, a) 30 count (NDC 00781-5938-31) and b) 90 count (NDC 00781-5938-92) bottles, Rx Only, Manufactured by Mylan Laboratories Limited Hyderabad 500 034, India for Sandoz Inc. Princeton, NJ 08540

Batch or Lot Expiration Information

Lot# a) 3022288 12/2015 3025988 03/2016 3025989 04/2016 3030459 08/2016 3030460 08/2016 3032087 10/2016 3032088 10/2016 3034506 12/2016 3035952 01/2017 3035953 01/2017 b) 3022287 12/2015 3025990 04/2016 3030458 08/2016 3032086 09/2016 3035954 01/2017