• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Enforcement Report - Week of February 17, 2016

  • Print
  • Share
  • E-mail
-

Product Detail

Product Description 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
Recall Number D-0659-2016
Classification Class III
Code Info 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
Product Distributed Qty 277,267 bottles
Reason For Recall Failed Impurities/Degradation Specifications; 9 month stability timepoint

Event Detail

Event Id 73035
Product Type Drugs
Status Ongoing
Recalling Firm Sandoz Inc
City Princeton
State NJ
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2015-12-31
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide
-
-