"Food and medicine" comes out preparations to treat high blood pressure due to impurities

Riyadh – Harmony:

The Saudi Food and Drug Authority (SFDA) has circulated to all health authorities a number of preparations used to treat high blood pressure and hypertension. heart failure following the presence of N-nitrosodimethylamine (NDMA)

The FDA, after reviewing its records, found a number of preparations that are produced using the active ingredient from this source: [19659004] Name Registration Number Operation Number Manufacturer 1 ] Film-coated tablet VALISTA 80 mg 311-212-14 All operations

Product previously manufactured to date

ACTAVIS 2 VALISTA 160 mg film-coated tablets 312-212-14 VALISTA 320 mg film-coated tablets 313-212-14 [19659013] CO-VALISTA 80 / 12.5 mg film-coated tablet 314-212-14 CO-VALISTA 160 / 12.5 mg film-coated tablet 315-212- CO-VALISTA 160/25 mg film-coated tablet 316-212-14 CO- VALISTA 320 / 12.5 mg film-coated tablet 317-212-14 8 CO-VALISTA film-coated tablet 320/25 mg 318-212-14 9 DIOSTAR 80 mg film-coated tablets 45-399-15 Pharma International Co. ] DIOSTAR 160 mg film-coated tablet 46-399-15 11 ] Film-coated tablet DIOSTAR PLUS 80 / 12.5 mg 47-399-17 12 ] Film-coated tablet DIOSTAR PLUS 160 / 12.5 mg [1 9459030] 011] 48-399-17 13 Film-coated tablet DIOSTAR PLUS 160/25 mg 49-399-17

The Bureau noted that the withdrawal of these preparations was a precautionary measure until the completion of the verification procedures. Valsartan is not affected by this article and should consult the doctor or pharmacist to find these alternatives. He asked consumers to inform the National Center for Vigilance and Safety of Medicine. If the side effects of the drug occur by toll free number: 8002490000, or fax: 00966112057662, or the common number: 1 9999, or e-mail: [email protected], or link: https : //ade.sfda.gov.sa