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Physician Sample Bottles Recalled; Multiple Medications in Bottles


On May 26, 2017, AstraZeneca recalled one lot of professional (physician) sample bottles containing eight tablets of Brilinta (ticagrelor) 90 mg tablets. The recall followed a report that a professional sample bottle containing eight tablets of Brilinta 90 mg also contained another medicine called Zurampic (lesinurad) 200 mg tablets which was also manufactured by AstraZeneca.

 

Brilinta is indicated to reduce the rate of death, heart attack, and stroke in patients with acute coronary syndrome (ACS) or a history of heart attack. Brilinta also reduces the rate of stent thrombosis in patients who have been stented for treatment of ACS. Brilinta has a warning in its prescribing information regarding discontinuation of the medicine. Missed doses of Brilinta increases the risk of heart attack and stroke. People who are treated with a stent and miss doses of Brilinta have a higher risk of getting a blood clot in the stent, having a heart attack, or dying. Patients should not stop taking Brilinta without talking to the prescribing doctor.

 

Zurampic is a prescription medicine used together with a xanthine oxidase inhibitor such as allopurinol or Uloric in adults with gout who still have a high uric acid level. Unintentional dosing with Zurampic has the potential to lead to adverse renal effects including acute renal failure which is more common when Zurampic is given alone as it should be used in combination with a xanthine oxidase inhibitor.

 

The recall applied to one lot (Brilinta lot #JB5047) of professional sample bottles containing eight tablets of Brilinta 90 mg distributed to physicians nationwide between March and April of 2017.

 

Brilinta 90 mg tablets are supplied as a round, biconvex, yellow, film-coated tablet, and imprinted with 90 above a T on one side of the pill. Zurampic tablets 200 mg are blue in color and elliptical/oval in shape. They are imprinted with LES200 on one side of the pill.

 

See the FDA Safety Alert

 

See the Recall

 

See also Medical Law Perspectives Report: Drugs, Dosage, and Damage: Physician Liability for Prescribing or Administering Medication

 

 

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