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Recall 2019-036: Aurobindo - Amlodipine Valsartan & Valsartan - NYC - Consumer


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

Description Lot # / Exp Date NDC UPC
AMLOD/VALSAR TB10/160MG AURO30 VFSA17007-A 10/31/2019 65862073930 36586273930
VALSARTAN TB 160MG AURO     90 472180009A 03/31/2020; 472180014A 04/30/2020 65862057290 36586257290
  472180010A 03/31/2020; 472180008A 03/31/2020    
  472180004A 01/31/2020; 472180003A 01/31/2020    
  472180002A 01/31/2020; 472180001A 01/31/2020    
  472180013A 04/30/2020; 472180007A 03/31/2020    
VALSARTAN TB 320MG AURO     90 473180005A 02/29/2020; 473180017A 05/31/2020 65862057390 36586257390
  473180006A 03/31/2020; 473180004A 02/29/2020    
  473170019A 10/31/2019; 473180016A 05/31/2020    
VALSARTAN TB 40MG AURO      30 470180008A 02/29/2020; 470180014A 03/31/2020 65862057030 36586257030
  470180016A 03/31/2020; 470180032A 05/31/2020    
VALSARTAN TB 80MG AURO      90 471180005A 02/29/2020; 471170015A 09/30/2019 65862057190 36586257190
  471180004A 02/29/2020    

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 February 01, 2018.

Patients who are prescribed Valsartan should continue taking their medication, as the risk of harm to the patient's health may be higher if the treatment is stopped immediately without any alternative treatment. Patients should contact their pharmacist or physician who can advise them about an alternative treatment prior to returning their medication.

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

Contact:

Aurobindo : Aurobindo Customer Service 866-850-2876