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Aurobindo Pharma Limited Issues Voluntary Recall of Irbesartan Drug Substance due to the Detection of Trace Amounts of NDEA (NNitrosodiethylamine) Impurity Found in the Active Pharmaceutical Ingredient (API)

Aurobindo Pharma Limited Issues Voluntary Recall of Irbesartan Drug Substance due to the Detection of Trace Amounts of NDEA (NNitrosodiethylamine) Impurity Found in the Active Pharmaceutical Ingredient (API)

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October 26, 2018

Audience: Consumer, Health Professional, Pharmacy

October 26, 2018 — Aurobindo Pharma Limited is voluntarily recalling 22 Batches of the drug substance Irbesartan due to the presence of an impurity, N-nitrosodiethylamine (NDEA). The impurity, which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, has been classified as a probable human carcinogen as per International Agency for Research on Cancer (IARC).

These 22 batches of Irbesartan drug substance were supplied to ScieGen Pharmaceuticals Inc., U.S. for the manufacturing of finished Irbesartan drug product (see attached annexure).

Aurobindo Pharma Limited has notified ScieGen Pharmaceuticals, Inc. of the recall and is arranging for the return of all available Irbesartan drug substance. Aurobindo Pharma Limited has further advised Sciegen Pharmaceuticals, Inc. to contact its distributors and retailers to return Irbesartan drug product and finished Irbesartan tablets that has been identified by Aurobindo Pharma Limited.

Patients should contact their pharmacist or physician who can advise them about an alternative treatment prior to returning their medication. Patients who are on Irbesartan should continue taking their medication, as the risk of harm to a patient’s health may be higher if the treatment is stopped immediately without any alternative treatment. Patients should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using Irbesartan.

Adverse reactions or quality problems associated with the use of this product may be reported to FDA’s MedWatch Adverse Event Reporting program either by phone, on line, by regular mail or by fax.

 Annexure -I
Irbesartan batches Supplied to US Customers


S.No Manufacturing Batch Number Dispatch Batch Number Date of Manufacture Date of Distribution Retest/Expiry Date Dispatch Qty Name and Location of the Customer NDEA Impurity Result ug/g
1 1601100782 1601101589 Jan-2016 Jan-2016 Dec-2016 90.29 Kg Sciegen Pharmaceuticals INC, USA 0.23
2 1601100783 1601101590 Jan-2016 3l-Jan-2016 Dec-2016 59.61 Kg Sciegen Pharmaceuticals INC, USA 0.28
3 1701111861 1701113404 l3-Sep-2017 7-0ct-2017 12-Sep-2020 88.48 Kg Sciegen Pharmaceuticals INC, USA 0.47
4 1701112170 1701113405 l8-Sep-2017 7-0ct-2017 l7-Sep-2020 90.92 Kg Sciegen Pharmaceuticals INC, USA 0.15
5 1701112501 1701113406 20-Sep-2017 7-0ct-2017 l9-Sep-2020 93.02 Kg Sciegen Pharmaceuticals INC, USA 1.61
6 1701112056 1701113407 l3-Sep-2017 7-0ct-2017 l2-Sep-2020 88.82 Kg Sciegen Pharmaceuticals INC, USA 0.53
7 1701112558 1701114283 2-0ct-2017 25-0ct-2017 l-Oct-2020 63.76 Kg Sciegen Pharmaceuticals INC, USA 0.6
8 1701112558 1701114284 2-0ct-2017 25-0ct-2017 l-Oct-2020 27.06 Kg Sciegen Pharmaceuticals INC, USA 0.6
9 1701I12559 1701114285 3-0ct-2017 25-0ct-2017 2-0ct-2020 91.82 Kg Sciegen Pharmaceuticals INC, USA 0.45
10 1701112589 1701114286 6-0ct-2017 25-0ct-2017 5-0ct-2020 90.32 Kg Sciegen Pharmaceuticals INC, USA 0.28
11 1701113300 1701114289 7-0ct-2017 25-0ct-2017 6-0ct-2020 91.32 Kg Sciegen Pharmaceuticals INC, USA 0.32
12 1701113301 1701114291 8-0ct-2017 25-0ct-2017 7-0ct-2020 90.12 Kg Sciegen Pharmaceuticals INC, USA 0.32
13 1701113302 1701114708 l7-0ct-2017 30-0ct-2017 l6-0ct-2020 80.82 Kg Sciegen Pharmaceuticals INC, USA 0.85
14 1701113312 1701114709 20-0ct-2017 30-0ct-2017 19 Oct 2020 86.82 Kg Sciegen Pharmaceuticals INC, USA 0.88
15 1701115460 1701117039 23-Nov-2017 2l-Dec-2017 22-Nov-2020 16.72 Kg Sciegen Pharmaceuticals INC, USA 0.31
16 1701115974 1701117040 29-Nov-2017 2l-Dec-2017 28-Nov-2020 91.12 Kg Sciegen Pharmaceuticals INC, USA 0.26
17 1701115460 1701117041 23-Nov-2017 2l-Dec-2017 22-Nov-2020 89.79 Kg Sciegen Pharmaceuticals INC, USA 0.31
18 1701115738 1701117042 24-Nov-2017 21-Dec-2017 23-Nov-2020 90.42 Kg Sciegen Pharmaceuticals INC, USA 0.38
19 1701115739 1701117043 25-Nov-2017 2l-Dec-2017 24-Nov-2020 89.79 Kg Sciegen Pharmaceuticals INC, USA 0.44
20 1701115740 1701117044 26-Nov-2017 2l-Dec-2017 25-Nov-2020 93.42 Kg Sciegen Pharmaceuticals INC, USA 0.34
21 1701115741 1701117045 27-Nov-2017 21-Dec-2017 26-Nov-2020 93.72 Kg Sciegen Pharmaceuticals INC, USA 0.39
22 1701115742 1701117046 28-Nov-2017 21-Dec-2017 27-Nov-2020 93.62 Kg Sciegen Pharmaceuticals INC, USA 0.31

Remark: For Dispatch batch no. 1701114283 & 1701114284, Mother Batch is common 170111255 8

For Dispatch batch no. 1701117039 & 1701117041, Mother Batch is common 1701115460

Total No. of Mother Batches: 20

Total No. of dispatch Batches: 22.

Source: FDA

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