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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)

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.NoManufacturing Batch NumberDispatch Batch NumberDate of ManufactureDate of DistributionRetest/Expiry DateDispatch QtyName and Location of the CustomerNDEA Impurity Result ug/g
116011007821601101589Jan-2016Jan-2016Dec-201690.29 KgSciegen Pharmaceuticals INC, USA0.23
216011007831601101590Jan-20163l-Jan-2016Dec-201659.61 KgSciegen Pharmaceuticals INC, USA0.28
317011118611701113404l3-Sep-20177-0ct-201712-Sep-202088.48 KgSciegen Pharmaceuticals INC, USA0.47
417011121701701113405l8-Sep-20177-0ct-2017l7-Sep-202090.92 KgSciegen Pharmaceuticals INC, USA0.15
51701112501170111340620-Sep-20177-0ct-2017l9-Sep-202093.02 KgSciegen Pharmaceuticals INC, USA1.61
617011120561701113407l3-Sep-20177-0ct-2017l2-Sep-202088.82 KgSciegen Pharmaceuticals INC, USA0.53
7170111255817011142832-0ct-201725-0ct-2017l-Oct-202063.76 KgSciegen Pharmaceuticals INC, USA0.6
8170111255817011142842-0ct-201725-0ct-2017l-Oct-202027.06 KgSciegen Pharmaceuticals INC, USA0.6
91701I1255917011142853-0ct-201725-0ct-20172-0ct-202091.82 KgSciegen Pharmaceuticals INC, USA0.45
10170111258917011142866-0ct-201725-0ct-20175-0ct-202090.32 KgSciegen Pharmaceuticals INC, USA0.28
11170111330017011142897-0ct-201725-0ct-20176-0ct-202091.32 KgSciegen Pharmaceuticals INC, USA0.32
12170111330117011142918-0ct-201725-0ct-20177-0ct-202090.12 KgSciegen Pharmaceuticals INC, USA0.32
1317011133021701114708l7-0ct-201730-0ct-2017l6-0ct-202080.82 KgSciegen Pharmaceuticals INC, USA0.85
141701113312170111470920-0ct-201730-0ct-201719 Oct 202086.82 KgSciegen Pharmaceuticals INC, USA0.88
151701115460170111703923-Nov-20172l-Dec-201722-Nov-202016.72 KgSciegen Pharmaceuticals INC, USA0.31
161701115974170111704029-Nov-20172l-Dec-201728-Nov-202091.12 KgSciegen Pharmaceuticals INC, USA0.26
171701115460170111704123-Nov-20172l-Dec-201722-Nov-202089.79 KgSciegen Pharmaceuticals INC, USA0.31
181701115738170111704224-Nov-201721-Dec-201723-Nov-202090.42 KgSciegen Pharmaceuticals INC, USA0.38
191701115739170111704325-Nov-20172l-Dec-201724-Nov-202089.79 KgSciegen Pharmaceuticals INC, USA0.44
201701115740170111704426-Nov-20172l-Dec-201725-Nov-202093.42 KgSciegen Pharmaceuticals INC, USA0.34
211701115741170111704527-Nov-201721-Dec-201726-Nov-202093.72 KgSciegen Pharmaceuticals INC, USA0.39
221701115742170111704628-Nov-201721-Dec-201727-Nov-202093.62 KgSciegen Pharmaceuticals INC, USA0.31

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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