AstraZeneca announced a voluntary recall of 1 lot of professional (physician) sample bottles containing Brilinta (ticagrelor) 90mg tablets as a precaution after a report showed the sample bottle contained Brilinta 90mg and Zurampic (lesinurad) 200mg tablets.
Brilinta is a P2Y12 platelet inhibitor indicated to reduce the rate of CV death, heart attack and stroke in patients with acute coronary syndrome (ACS) or a history of heart attack. It is also indicated to reduce the rate of stent thrombosis in patients who have been stented for ACS. Zurampic is a URAT1 inhibitor used in combination with a xanthine oxidase inhibitor such as allopurinol or Uloric in adults with gout who still have a high uric acid level.
This recall affects Lot #JB5047 of the professional sample bottles containing 8 Brilinta 90mg tablets. They were distributed between March and April 2017. Other dosage strengths or forms of Brilinta or Zurampic are not affected by this recall.
Accidental patient dosing with Zurampic can potentially cause adverse renal effects such as acute renal failure; this is more common if Zurampic is given alone without a xanthine oxidase inhibitor. If the patient misses a dose of Brilinta, it may lead to an increased risk of heart attack or stroke. Patients with a stent who miss doses of Brilinta have an increased risk of getting a blood clot in the stent, heart attack, or death.
To date, the Company has not received any adverse event reports from the recall.
For more information call (800) 236-9933 or visit AstraZeneca-US.com.