Eptifibatide Recall: Slate Run Pharmaceuticals 70436-027-80
Announced 2026-03-04 · FDA
The FDA is recalling Slate Run Pharmaceuticals Eptifibatide Injection, 75 mg/100 mL vial for weight-adjusted bolus dosing, distributed nationwide in the U.S. The recall is due to labeling discrepancies: the carton states weight-adjusted bolus dosing, while the approved labeling describes weight-adjusted infusion. The recall applies to all lots within expiry; no corrective action is specified in the information provided.
| Brand | Slate Run Pharmaceuticals |
|---|---|
| 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. |
| Severity | low |
| Units affected | N/A |
| Distribution | Nationwide within the USA. |
| Agency | FDA |
| Recall / campaign no. | All lots within expiry |
WHAT YOU SHOULD DO
- Do not use any product labeled as Eptifibatide Injection 75 mg/100 mL if it shows weight-adjusted bolus dosing on the carton; verify the NDC 70436-027-80.
- Contact your healthcare provider or pharmacist for guidance and arrange for return or disposal according to local recall instructions.
- Keep all packaging and recall materials until guidance is given, and watch for updates from the FDA or Slate Run Pharmaceuticals.
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.