FDA Drug recall D-0343-2026
Eptifibatide Injection, 75 mg/100 mL vial for weight-adjusted bolus dosing, 1x100 mL Single-dose Vial, For Intravenous Use Only, Rx Only, M…
- FDA Drug
- Class III
- ongoing
- Published 2026-03-04
On 2026-03-04 the FDA classified a Class III recall of Eptifibatide Injection, 75 mg/100 mL vial for weight-adjusted bolus dosing, 1x100 mL Single-dose Vial, For Intravenous Use Only, Rx Only, M… by Slate Run Pharmaceuticals, citing labeling: Not Elsewhere Classified. The carton for Eptifibatide Injection 75 mg/100 mL states 75 mg/100 mL vial for weight-adjusted bolus dosing. The approved statement is 75 mg/1….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0343-2026 |
| Classification | Class III |
| Status | ongoing |
| Initiated | 2026-02-12 |
| Published | 2026-03-04 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Slate Run Pharmaceuticals |
| Distribution | US |
Product
Eptifibatide Injection, 75 mg/100 mL vial for weight-adjusted bolus dosing, 1x100 mL Single-dose Vial, For Intravenous Use Only, Rx Only, Manufactured by: Hainan Poly Pharm. Co., Ltd., Guilinyang Economic Development Area, Haikou, Hainan Province, China 571127; Distributed by: Slate Run Pharmaceuticals, LLC, Columbus, Ohio 43215. NDC Slate Run Carton Label: 70436-027-80; NDC ProRx Carton Label: 70436-163-80
Reason
Labeling: Not Elsewhere Classified. The carton for Eptifibatide Injection 75 mg/100 mL states 75 mg/100 mL vial for weight-adjusted bolus dosing. The approved statement is 75 mg/100 mL vial for weight-adjusted infusion.
Identifiers
| ndc | 70436-026-80 |
|---|---|
| ndc | 70436-027-80 |
| ndc | 70436-162-80 |
| ndc | 70436-163-80 |
| code_info | All lots within expiry |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0343-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.