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Recall Observatory FDA recall evidence

Drug product

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.

D-0958-2017

May 25, 2017

Class I

Product summary

Firm
AstraZeneca Pharmaceuticals, LP
Event
Event 77336
Status
Terminated
Classification
Class I
Quantity
40,368 bottles
Official record key
drug-enforcement:D-0958-2017

Official wording

Reason: 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.

Code information: Lot # JB5047, Exp 10/19

Distribution pattern: Nationwide in the USA and Puerto Rico to physician offices.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.