May 2017 FDA Recall Brilinta by Astrazeneca Pharmaceuticals, Lp
D-0958-2017 - Presence of Foriegn Tablets/Capsules
This Class I drug recall was voluntarily initiated by Astrazeneca Pharmaceuticals, Lp on May 25, 2017 for the product Brilinta. The FDA reported the reason for recall as presence of foriegn tablets/capsules. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0958-2017
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.
05-25-2017
07-19-2017
40,368 bottles
Recall Profile & Regulatory Data
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
AstraZeneca Pharmaceuticals, LP
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the USA and Puerto Rico to physician offices.
04-24-2018
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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.
Batch or Lot Expiration Information
Lot# JB5047, Exp 10/19
