FDA Recall D-0958-2017
AstraZeneca Pharmaceuticals, LP · Newark, DE
Class I — life-threatening Terminated 334 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
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.
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.
Recall record
- Recall number
D-0958-2017- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Press Release
- Distribution
- Nationwide in the USA and Puerto Rico to physician offices.
- Recall initiated
- 2017-05-25
- Classified by FDA Center
- 2017-07-11
- FDA published
- 2017-07-19
- Terminated
- 2018-04-24
- Recalling firm
- AstraZeneca Pharmaceuticals, LP
- Firm location
- Newark, DE
Drug identification
- Brand name(s)
- BRILINTA
- Generic name(s)
- TICAGRELOR
- Manufacturer(s)
- AstraZeneca Pharmaceuticals LP
- NDC(s)
0186-0776, 0186-0777- Route(s)
- ORAL