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Recall 2019-002: Aurobindo - Valsartan - NYC - Consumer


URGENT!!!            DRUG RECALL!!!            URGENT!!!

Description Lot # Exp Date NDC UPC
AMLOD/VALSAR TB 5/160MG AURO30 VESA17014-A 10/31/2019 65862073730 36586273730
  VESA18001-A 12/31/2019    
  VESA18002-A 12/31/2019    
  VESA17013-A 10/31/2019    
AMLOD/VALSAR TB 5/320MG AURO30 VMSA17012-A 11/30/2019 65862073830 36586273830
  VMSA17013-A 11/30/2019    
  VMSA17014-A 11/30/2019    
  VMSA17015-A 11/30/2019    
  VMSA17016-A 11/30/2019    
  VMSA17017-A 11/30/2019    
AMLOD/VALSAR TB10/160MG AURO30 VFSA18007-A 3/31/2020 65862073930 36586273930
  VFSA18003-A 1/31/2020    
  VFSA17008-A 10/31/2019    
  VFSA18002-A 1/31/2020    
  VFSA18008-A 3/31/2020    
  VFSA17010-A 10/31/2019    
  VFSA17009-A 10/31/2019    
AMLOD/VALSAR TB10/320MG AURO30 VKSA18001-A 1/31/2020 65862074030 36586274030
  VKSA17008-A 5/31/2019    
  VKSA17017-A 10/31/2019    
  VKSA17015-A 10/31/2019    
  VKSA18004-A 1/31/2020    
  VKSA18005-A 3/31/2020    
  VKSA18002-A 1/31/2020    
  VKSA17016-A 10/31/2019    
  VKSA17014-A 10/31/2019    
VALSART/HCTZ 160/25MG AURO90 HVSB17038-A 11/30/2020 65862054990 36586254990
  HVSB18003-A 12/31/2020    
  HVSB18001-A 12/31/2020    
  HVSB17036-A 11/30/2020    
  HVSB17039-A 11/30/2020    
  HVSB18004-A 12/31/2020    
  HVSB18002-A 12/31/2020    
  HVSB17037-A 11/30/2020    
  HVSB17023-A 8/31/2020    
  HVSB17040-B 11/30/2020    
VALSART/HCTZ 320/25MG AURO90 HTSB18006-A 12/31/2020 65862055190 36586255190
  HTSB17068-A 11/30/2020    
  HTSB18001-A 12/31/2020    
  HTSB18003-A 12/31/2020    
  HTSB18007-A 12/31/2020    
  HTSB17063-A 10/31/2020    
  HTSB17055-A 10/31/2020    
  HTSB17056-A 10/31/2020    
  HTSB17058-A 10/31/2020    
  HTSB17060-A 10/31/2020    
  HTSB17064-A 10/31/2020    
  HTSB17067-A 11/30/2020    
  HTSB17069-A 11/30/2020    
  HTSB18002-A 12/31/2020    
  HTSB18005-A 12/31/2020    
  HTSB18029-A 3/31/2021    
  HTSB18004-A 12/31/2020    
  HTSB17065-A 10/31/2020    
  HTSB17057-A 10/31/2020    
  HTSB17059-A 10/31/2020    
  HTSB17062-A 10/31/2020    
  HTSB17049-A 8/31/2020    
  HTSB17066-A 10/31/2020    
  HTSB17054-A 10/31/2020    
VALSART/HCTZ 80/12.5MG AURO90 HVSA17011-A 11/30/2020 65862054790 36586254790
  HVSA18001-A 12/31/2020    
  HVSA17012-A 11/30/2020    
VALSART/HCTZ 160/ 12.5MG AURO90 HTSA17033-A 10/31/2020 65862054890 36586254890
  HTSA17043-A 11/30/2020    
  HTSA17041-A 11/30/2020    
  HTSA17037-A 10/31/2020    
  HTSA17034-A 10/31/2020    
  HTSA17040-A 10/31/2020    
  HTSA17042-A 11/30/2020    
  HTSA17039-A 10/31/2020    
  HTSA17036-A 10/31/2020    
  HTSA17035-A 10/31/2020    
VALSART/HCTZ 320/ 12.5MG AURO90 HRSA17033-A 10/31/2020 65862055090 36586255090
  HRSA17035-A 10/31/2020    
  HRSA17037-A 10/31/2020    
  HRSA17034-A 10/31/2020    
  HRSA17036-A 10/31/2020    
VALSARTAN TB 320MG AURO VUSD17009-A 9/30/2019 65862057390 36586257390
  VUSD17008-A 7/31/2019    


Aurobindo is voluntarily recalling the above items/lots due to the detection of trace amounts of an unexpected impurity found in the finished drug product.  This recall is to the Consumer level.  Affected product started shipping May 01, 2016.

Consumers should also contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Any general questions regarding the return of this product please contact Inmar\CLS-Medturn at 1-877-208-2407 or email rxrecalls@inmar.com (live calls received 9 am -5:00 pm Eastern Time).

This recall is being conducted with the knowledge of the FDA.

Contact:

rxrecalls@inmar.com: Inmar CLS-Medturn 877-208-2407