FDA-Drug2017-07-19Class I

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.

AstraZeneca Pharmaceuticals, LP
Hazard

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.

Sold states
Nationwide in the USA and Puerto Rico to physician offices.
Affected count
40,368 bottles
Manufactured in
587 Old Baltimore Pike, Newark, DE, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0958-2017

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