PlainRecalls
FDA Drug Critical Class I Terminated

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.

Reported: July 19, 2017 Initiated: May 25, 2017 #D-0958-2017

Product Description

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.

Reason for Recall

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.

Details

Units Affected
40,368 bottles
Distribution
Nationwide in the USA and Puerto Rico to physician offices.
Location
Newark, DE

Frequently Asked Questions

What product 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.. Recalled by AstraZeneca Pharmaceuticals, LP. Units affected: 40,368 bottles.
Why was this product 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.
Which agency issued this recall?
This recall was issued by the FDA Drug on July 19, 2017. Severity: Critical. Recall number: D-0958-2017.