Irbesartan Bulk Active Pharmaceutical Ingredient.

Is this the product you have?

• Irbesartan Bulk Active Pharmaceutical Ingredient.

Lot codes and dates

• Manufacturing batch numbers
  • 1601100782
  • dispatch batch number 1601101589
  • exp. date 12/01/2018 1601100783
  • dispatch batch number 1601101590
  • exp. date 12/01/2018 1701111861
  • dispatch batch number 1701113404
  • exp. date 09/01/2020 1701112170
  • dispatch batch number 1701113405
  • exp. date 09/01/2020 1701112501
  • dispatch batch number 1701113406
  • exp. date 09/01/2020 1701112056
  • dispatch batch number 1701113407
  • exp. date 09/01/2020 1701112558
  • dispatch batch number 1701114283
  • exp. date 10/01/2020 1701112559
  • dispatch batch number 1701114285
  • exp. date 10/01/2020 1701112589
  • dispatch batch number 1701114286
  • exp. date 10/01/2020 1701113300
  • dispatch batch number 1701114289
  • exp. date 10/01/2020 1701113301
  • dispatch batch number 1701114291
  • exp. date 10/01/2020 1701113302
  • dispatch batch number 1701114708
  • exp. date 10/01/2020 1701113312
  • dispatch batch number 1701114709
  • exp. date 10/01/2020 1701115460
  • dispatch batch number 1701117039
  • exp. date 11/01/2020 1701115974
  • dispatch batch number 1701117040
  • exp. date 11/01/2020 1701115460
  • dispatch batch number 1701117041
  • exp. date 11/01/2020 1701115738
  • dispatch batch number 1701117042
  • exp. date 11/01/2020 1701115739
  • dispatch batch number 1701117043
  • exp. date 11/01/2020 1701115740
  • dispatch batch number 1701117044
  • exp. date 11/01/2020 1701115741
  • dispatch batch number 1701117045
  • exp. date 11/01/2020 1701115742
  • dispatch batch number 1701117046
  • exp. date 11/01/2020

Amount recalled

1724.8 kgs.

Where it was sold

• NY

Why it was recalled

CGMP Deviation: Presence of NDEA (N-Nitrosodimethylamine), a carcinogen impurity, detected in the active ingredient.

This product could cause temporary or reversible health problems — stop using it.