D-0958-2017 Class I Terminated
FDA drug recall D-0958-2017 was initiated by AstraZeneca Pharmaceuticals, LP on May 25, 2017 and is designated Class I. 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… The recall status is terminated (terminated Apr 24, 2018). Affected quantity: 40,368 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Jul 19, 2017
- Initiation Date
- May 25, 2017
- Termination Date
- Apr 24, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 40,368 bottles
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.
Distribution Pattern
Nationwide in the USA and Puerto Rico to physician offices.
Code Information
Lot # JB5047, Exp 10/19
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0958-2017
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026