Recalls / Class I
Class ID-0958-2017
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences 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.
- Brand name
- Brilinta
- Generic name
- Ticagrelor
- Active ingredient
- Ticagrelor
- Route
- Oral
- NDCs
- 0186-0776, 0186-0777
- FDA application
- NDA022433
- Affected lot / code info
- Lot # JB5047, Exp 10/19
Why it was 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.
Recalling firm
- Firm
- AstraZeneca Pharmaceuticals, LP
- Manufacturer
- AstraZeneca Pharmaceuticals LP
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 587 Old Baltimore Pike, Newark, Delaware 19702-1307
Distribution
- Quantity
- 40,368 bottles
- Distribution pattern
- Nationwide in the USA and Puerto Rico to physician offices.
Timeline
- Recall initiated
- 2017-05-25
- FDA classified
- 2017-07-11
- Posted by FDA
- 2017-07-19
- Terminated
- 2018-04-24
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0958-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.