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Recall 2018-205: Mylan - Valsartan - NYC - Consumer


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

Description       Lot #      Exp Date         NDC       UPC
AMLOD/VALSAR TB10/160MG 3079500 01/31/2020   00378172293  30378172293
AMLOD/VALSAR TB10/320MG  3079709 01/31/2020   00378172493  30378172493
  3079708 01/31/2020  
  3077618 11/30/2019  
  3061986 11/30/2018    
AMLOD/VALSART TB5/160MG 3066051 03/31/2019   00378172193  30378172193
VALS+HYDR TB320MG/25MG 3093804 12/31/2019   00378632505  30378632505
  3084886 02/28/2019    
VALSARTAN TAB 160 MG 3071352 07/31/2019   00378581477  30378581477
VALSARTAN TAB 320 MG 3081499 03/31/2020   00378581577  30378581577
  3080010 02/28/2020  
  3080009 02/28/2020  
  3079205 01/31/2020    
VALSARTAN TAB 40 MG 3061169 11/30/2018   00378580793  30378580793
VALSARTAN TAB 80 MG 3063782 01/31/2019   00378581377  30378581377


Mylan Pharmaceuticals is voluntarily recalling the above item(s)/lot(s) due to detected trace amounts of an impurity N-nitrosodieethylamine (NDEA). This recall is to the Consumer level.  Affected product started shipping March 2017.

Consumers should contact their pharmacist or physician who can advise them about an alternative treatment prior to returning their medication. Patients who are on 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.

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

Contact:

Stericycle: Stericycle Solco Healthcare 888-871-7116