Brilinta Tablet
FDA Recall NDC 0186-0776
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Brilinta (NDC 0186-0776). A significant event, classified as Class II, was initiated on Mar 15, 2021 by Astrazeneca Pharmaceuticals Lp. The reported reason for this action was: "CGMP Deviations: Intermittent exposure to temperature excursion during storage."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Mar 15, 2021
Jun 02, 2021
1278 bottles
Recall Profile & Regulatory Data
Event ID
87512
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Cardinal Health Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
FL, GA, SC
Termination Date
Jun 17, 2024
Product Description
Brilinta ticagrelar tablets 60 mg 60 tablets Rx only NDC 0186-0776-60 Mfd. for: AstraZeneca LP, Wilmington, DE 19850
Batch or Lot Expiration Information
Lot# MP0138
Affected Packages Involved in this Recall
0186-0777-08Product
0186-0777-60Product
0186-0777-18Product
0186-0777-39Product
0186-0777-28Product
0186-0776-60Product
0186-0776-94Product
Class I Terminated
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.
May 25, 2017
Jul 19, 2017
40,368 bottles
Recall Profile & Regulatory Data
Event ID
77336
Classification
Class I
Enforcement Status
Terminated
Recalling Firm
AstraZeneca Pharmaceuticals, LP
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA and Puerto Rico to physician offices.
Termination Date
Apr 24, 2018
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.
Batch or Lot Expiration Information
Lot# JB5047, Exp 10/19
Affected Packages Involved in this Recall
0186-0777-08Product
0186-0777-60Product
0186-0777-18Product
0186-0777-39Product
0186-0777-28Product
0186-0776-60Product
0186-0776-94Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
