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  4. Astrazeneca Initiates Voluntary Nationwide Recall of One Lot of Brilinta 90 mg Professional Sample Bottles Due to Report of Another Medicine in One Bottle From That Lot
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COMPANY ANNOUNCEMENT

Astrazeneca Initiates Voluntary Nationwide Recall of One Lot of Brilinta 90 mg Professional Sample Bottles Due to Report of Another Medicine in One Bottle From That Lot

When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.

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Summary

Company Announcement Date:
FDA Publish Date:
Product Type:
Drugs
Generic Drugs
Reason for Announcement:
Recall Reason Description
Another medicine present
Company Name:
Astrazeneca
Brand Name:
Brand Name(s)
Astrazeneca
Product Description:
Product Description
professional (physician) sample BRILINTA (ticagrelor) 90mg tablets

Company Announcement

Voluntary recall limited to Lot # JB5047 of BRILINTA® (ticagrelor) 90 mg tablets, 8-count Professional (Physician) Sample Bottles

Other forms or dosage strengths of BRILINTA, including medicine obtained via US retail or mail order pharmacies, are not affected by this voluntary recall

AstraZeneca today announced that the Company is notifying physicians and consumers that it is voluntarily recalling one lot of professional (physician) sample bottles containing eight tablets of BRILINTA® (ticagrelor) 90mg tablets as a precautionary measure. This voluntary recall follows a report that a professional sample bottle containing eight tablets of BRILINTA 90mg also contained another medicine called ZURAMPIC® (lesinurad) 200 mg tablets which is also manufactured by AstraZeneca.

This precautionary measure is limited to one lot (BRILINTA lot #JB5047) of professional sample bottles containing eight tablets of BRILINTA 90 mg distributed to physicians in the US between March and April of 2017. Other forms and dosage strengths of BRILINTA, including medicine obtained via US retail or mail order pharmacies, are not affected by this voluntary recall. This recall does not affect ZURAMPIC.

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. 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 death. Patients should not stop taking BRILINTA without talking to their prescribing doctor. To date, AstraZeneca has not received any reports of adverse events related to this recall.

BRILINTA is 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. BRILINTA also reduces the rate of stent thrombosis in patients who have been stented for treatment of ACS. 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.

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.

AstraZeneca is notifying physicians by recall letter and is arranging for return of all recalled products. Consumers that have medicine which is being recalled should contact their physician.

Consumers with questions regarding this recall can contact AstraZeneca Information Center at 1-800-236-9933 between the hours of 8 a.m. and 6 p.m. (Eastern Time) Monday to Friday, excluding holidays. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this medicine.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Patient safety is a top priority for AstraZeneca and we are working closely on this recall with the knowledge of the U.S. Food and Drug Administration in taking the appropriate course of action.​​​​​​


Company Contact Information

Consumers:
1-800-236-9933
Media:
Michele Meixell; Alex Engel
1 (302) 885-2677; 1 (302) 885-2677

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