The Recall Desk
SevereFDA (Drugs)·D-0958-2017·Announced 2017-07-19

AstraZeneca Recalls BRILINTA Tablets Due to Foreign Zurampic Contamination

AstraZeneca is recalling 40,368 bottles of BRILINTA 90 mg tablets because some bottles contained foreign Zurampic tablets.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class I, which indicates a reasonable probability that use of the product will cause serious adverse health consequences or death. The presence of foreign tablets (Zurampic) in a BRILINTA bottle represents a significant medication error risk.

Plain-English summary

AstraZeneca Pharmaceuticals, LP is recalling 40,368 bottles of BRILINTA (ticagrelor) 90 mg tablets, 8-count professional sample bottles. The recall was initiated after a customer complaint reported that an 8-count bottle labeled as BRILINTA 90 mg tablets contained five ZURAMPIC 200 mg tablets in addition to the expected eight BRILINTA tablets.

The affected product is identified by Lot # JB5047 with an expiration date of 10/19. The product was distributed nationwide in the USA and Puerto Rico to physician offices. BRILINTA is a prescription-only medication manufactured by AstraZeneca Pharmaceuticals LP.

Physicians and healthcare providers should stop using the affected BRILINTA bottles and return them to the manufacturer. Patients who may have received these specific bottles should contact their healthcare provider for guidance.

The recalled product

Product
BRILINTA (TICAGRELOR)
Brand
BRILINTA
Affected units
40,368

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot # JB5047
  • Exp 10/19

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Same brand · BRILINTA