Irbesartan Bulk Active Pharmaceutical Ingredient.

FDA recall notice · announced November 7, 2018 · Aurobindo Pharma Limited (unit I)

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

Reason for recall

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

Notes

Distribution: Product was distributed to one customer in NY.
Lot/code information: 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
Quantity: 1724.8 kgs.
Status: Terminated
Products in this recall event:
- Irbesartan Bulk Active Pharmaceutical Ingredient. (D-0127-2019)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.