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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 77336

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
May 25, 2017
Product types
Drug
Classifications
Class I
Statuses
Terminated
Recalling firm wording
AstraZeneca Pharmaceuticals, LP

Dossier provenance

Source snapshots represented here

  • openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 1

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.

D-0958-2017
Recall number
D-0958-2017
Initiated
May 25, 2017
Classification
Class I
Status
Terminated
Quantity
40,368 bottles

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

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.

Code information

Lot # JB5047, Exp 10/19

Distribution pattern

Nationwide in the USA and Puerto Rico to physician offices.