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
- Recalling Firm
- AstraZeneca Pharmaceuticals, LP
- 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.
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