Severity
Critical
CriticalClass ITerminated
FDA Drug recall · Reported July 19, 2017
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.
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 addit…
AstraZeneca Pharmaceuticals, LP recalled BRILINTA (ticagrelor) tablets, 90 mg, 8-count Professional Sample bottles, Rx only, Mfd. … - a critical-severity action.
BRILINTA (ticagrelor) tablets, 90 mg, 8-count Professional Sample bottles, Rx only, Mfd. … was recalled by AstraZeneca Pharmaceuticals, LP in July 19, 2017. Reason: Presence of Foriegn Tablets/Capsules: customer complaint that an 8-count professional sample bottle labeled a…. Check the official notice for the remedy. Verify recall #D-0958-2017 with the FDA Drug before acting.
The recall
AstraZeneca Pharmaceuticals, LP issued this critical-severity FDA Drug recall-Presence of Foriegn Tablets/Capsules: customer complaint that an 8-count professional sample bottle labeled a….
- Critical
- severity level
- Class I
- classification
- July 19, 2017
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-0958-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-0958-2017) was formally reported on July 19, 2017, with the manufacturer initiating the action on May 25, 2017. It is classified under Critical severity (Class I), with a current status of Terminated. AstraZeneca Pharmaceuticals, LP is listed as the recalling firm, operating out of Newark, DE. Federal records list the affected scope as 40,368 bottles.
The documented reason for this recall is: 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 data in the federal record shows the product reached: Nationwide in the USA and Puerto Rico to physician offices.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Children & Baby Products recalls over time
Where this recall sits in its category - 3,731 children & baby products recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
40,368 bottles
Related Recalls
6
0 from same agency
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | D-0958-2017 |
| Date reported | July 19, 2017 |
| Date initiated | May 25, 2017 |
| Recalling firm | AstraZeneca Pharmaceuticals, LP |
| Firm location | Newark, DE |
| Affected scope | 40,368 bottles |
| Distribution | Nationwide in the USA and Puerto Rico to physician offices. |
Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (D-0958-2017) and product description against the item you own. Search the archive
- Confirm the current status with FDA Drug before acting, recall details can be updated.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. What to do next
This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by AstraZeneca Pharmaceuticals, LP. Units affected: 40,368 bottles.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 19, 2017. Severity: Critical. Recall number: D-0958-2017.
Where was the recalled product distributed? ▼
Distribution: Nationwide in the USA and Puerto Rico to physician offices..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-0958-2017) against your product. Visit the official FDA Drug website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Drug, reported July 19, 2017. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.