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VALSARTANDAN SONRA BAZI IRBESARTANLARDA DA KANSEROJEN MADDE TESBİT EDİLDİ

VALSARTANDAN SONRA DİĞER HİPERTANSİYON İLACI IRBERSARTANDA DA KANSEROJEN MADDE BULUNDU VE ABD DE BAZI FİRMALAR İLAÇLARI GÖNÜLLÜ OLARAK TOPLATTI. TÜRKİYE HAKKINDA HENÜZ BİR BİLGİ YOK VE TÜRKİYEDE KULLANILAN IRBERSARTAN ETKEN MADDENİN FDA DE ADI GEÇEN FİRMALARDAN ALINIP ALINMADIĞI HERHALDE HASTALARI ENDİŞELENDİRMEMEK İÇİN TİTCK TARAFINDAN AÇIKLANACAKTIR. BİLİNDİĞ GİBİ İÇİNDE KANSEROJEN MADDE BULUNAN, ÖZELLİKLE ÇİN MENŞELİ VALSARTAN İHTİVA EDEN JENERİKLER ABD VE AVRUPADA YASAKLANDIKTAN ÇOK SONRA TÜRKİYEDE DE YASAKLANMIŞTI.

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)

For Immediate Release

October 26, 2018

Ms. Blessy Johns
732-839-4380

Announcement

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.

İlaç Eşdeğerleri (irbesartan etkin maddesini içeren ilaçlar)
ARBESTA 150 MG 28 FILM TABLET19,59TLALI RAIF

ARBESTA 150 MG 90 FILM TABLET62,72TLALI RAIF

ARBESTA 300 MG 28 FILM TABLET26,27TLALI RAIF

ARBESTA 300 MG 90 FILM TABLET84,05TLALI RAIF

IRBECOR 150 MG 28 FILM KAPLI TABLET12,41TLILKO

IRBECOR 300 MG 28 FILM KAPLI TABLET20,56TLILKO

IRBEDAY 150 MG 28 FILM KAPLI TABLET15,83TLVITALIS

IRBEDAY 300 MG 28 FILM KAPLI TABLET26,1TLVITALIS

IRBEDAY 75 MG 28 FILM KAPLI TABLET9,78TLVITALIS

IRBETAB 150 MG 28 TABLET19,59TLZENTIVA

IRBETAB 300 MG 28 TABLET26,27TLZENTIVA

IRBETAB 75 MG 28 TABLET9,78TLZENTIVA

IRDA 150 MG 28 FİLM TABLET15,73TLNOBEL ILAC SANAYI

IRDA 150 MG 90 FİLM TABLET62,72TLNOBEL ILAC SANAYI

IRDA 300 MG 28 FİLM TABLET18,6TLNOBEL ILAC SANAYI

IRDA 300 MG 90 FİLM TABLET84,05TLNOBEL ILAC SANAYI

IRDA 75 MG 28 FILM TABLET9,78TLNOBEL ILAC SANAYI

IRPRESTAN 150 MG 28 FILM TABLET14,37TLACTAVIS ILAC

IRPRESTAN 300 MG 28 FILM TABLET22,22TLACTAVIS ILAC

KARVEA 150 MG 28 FİLM KAPLI TABLET19,59TLSANOFI SAGLIK URUNLERI

KARVEA 300 MG 28 FİLM KAPLI TABLET26,27TLSANOFI SAGLIK URUNLERI

KARVEA 75 MG 28 TABLET9,78TLSANOFI SAGLIK URUNLERI

ONESART 150 MG 28 FILM TABLET hkt - küb12,44TLBIOFARMA

ONESART 150 MG 90 FILM TABLET hkt - küb39,85TLBIOFARMA

ONESART 300 MG 28 FILM TABLET hkt - küb14,71TLBIOFARMA

ONESART 300 MG 90 FILM TABLET hkt - küb47,86TLBIOFARMA

REBEVEA 150 MG 28 FILM TABLET14,4TLPHARMACTIVE

REBEVEA 300 MG 28 FILM TABLET21,84TLPHARMACTIVE

REBEVEA 75 MG 28 FILM TABLET9,78TLPHARMACTIVE

ROTAZAR 150 MG 28 FILM TABLET19,49TLWORLD MEDICINE

ROTAZAR 300 MG 28 FILM TABLET26,27TLWORLD MEDICINE

ROTAZAR 75 MG 28 FILM TABLET9,78TLWORLD