AstraZeneca Pharmaceuticals, LP recalls BRILINTA (ticagrelor) tablets, 90 mg, 8-count Professional Sample bottles, Rx only, Mfd. for: AstraZeneca Pharmaceutica…

Recall date

May 25, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0958-2017

FDA classification

Class I

Brand / firm

AstraZeneca Pharmaceuticals, LP

Sold / distributed

Nationwide in the USA and Puerto Rico to physician offices.

Why it was recalled

Presence of Foriegn Tablets/Capsules: customer complaint that an 8-count professional sample bottle labeled as BRILINTA 90 mg tablets contained 5 ZURAMPIC 200 mg tablets, in addition to the expected 8 BRILINTA tablets.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

BRILINTA (ticagrelor) tablets, 90 mg, 8-count Professional Sample bottles, Rx only, Mfd. for: AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850; By: AstraZeneca AB, SE-151 85 Sodertalje, Sweden, NDC 0186-0777-08.