FDA Drug recall D-0958-2017
BRILINTA (ticagrelor) tablets, 90 mg, 8-count Professional Sample bottles, Rx only, Mfd. for: AstraZeneca Pharmaceuticals LP, Wilmington, D…
- FDA Drug
- Class I
- terminated
- Published 2017-07-19
On 2017-07-19 the FDA classified a Class I recall of BRILINTA (ticagrelor) tablets, 90 mg, 8-count Professional Sample bottles, Rx only, Mfd. for: AstraZeneca Pharmaceuticals LP, Wilmington, D… by Astrazeneca Pharmaceuticals, citing 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….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0958-2017 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2017-05-25 |
| Published | 2017-07-19 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Astrazeneca Pharmaceuticals |
| Distribution | US |
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.
Reason
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.
Identifiers
| ndc | 0186-0777-08 |
|---|---|
| ndc | 0186-0777-60 |
| ndc | 0186-0777-18 |
| ndc | 0186-0777-39 |
| ndc | 0186-0777-28 |
| ndc | 0186-0776-60 |
| ndc | 0186-0776-94 |
| code_info | Lot # JB5047, Exp 10/19 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0958-2017%22
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