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)
- Company Announcement Date:
- October 26, 2018
- FDA Publish Date:
- April 11, 2019
- Product Type:
- Reason for Announcement:
Recall ReasonDevice & Drug Safety, Potential Foreign Material
- Company Name:
- Aurobindo Pharma Limited
- Brand Name:
Brand Name(s)Aurobindo Pharma Limited
- Product Description:
Product DescriptionIrbesartan Drug
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.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.
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.
Company Contact Information
- Ms. Blessy Johns