Home
Disease Knowledge Center Drug Hub Monographs Drug Interactions Pregnancy Drug Safety Drug Recalls & Alerts OTC Navigator
Virtual Simulators Hub Clinical Cases Simulator Nutrition & Macro Calculator
Questo Insights Global Opportunities Hub AI Research Assistant Citation & Reference Generator Scholarships & Essay Planner Visa & Mobility Navigator English Assessment Test
Verified Jobs Board Pharmacy Clearance Pharmacies Directory
Practice Quizzes STEM Academy Toolkits
Medical Case Donations Opportunity Crowdfunding Community Forums Courses Academy
Back to Drug Recalls Center
Home Drug Recalls D-0343-2026
Class III — Low Risk Severity Status: Ongoing Authority: FDA

EPTIFIBATIDE

Recalling Firm / Manufacturer: Slate Run Pharmaceuticals (Columbus, OH, United States)
FDA Recall Number: D-0343-2026
View FDA Source
Source Authority Disclaimer: This drug recall notice is published by Questo using official enforcement reports issued by the U.S. Food & Drug Administration (FDA). It is provided for informational, academic, and clinical research purposes only. Patients should not discontinue prescribed treatments without consulting their physician or pharmacist.
Product & Identification Information
Brand, active ingredients, NDC codes, and manufacturer details
Brand / Trade Name
EPTIFIBATIDE
Generic Name
EPTIFIBATIDE
Active Substance(s)
Eptifibatide
Administration Route
Intravenous
National Drug Code (NDC)
70436-026
Total Quantity Recalled
N/A
Official Reason for Recall
Specific hazard or quality defect cited by the FDA

According to the official FDA enforcement report:

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.

Full Product Description
Packaging specifications and labeling details

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

Enforcement & Regulatory Details
FDA classification, report dates, and initiation authority
Health Hazard Classification
Class III
Current Action Status
Ongoing
FDA Enforcement Report Date
March 04, 2026
Firm Initiation Date
February 12, 2026
FDA Classification Date
Feb 23, 2026
Initiation Type
Voluntary: Firm initiated
Affected Lots & Batch Numbers
Product codes, lot numbers, and expiration dates
All lots within expiry
Distribution Information
Geographic scope of affected shipments

Nationwide within the USA.

Safety Guidance & Actions
Standard FDA protocol for patients and healthcare providers
Advisory Notice
This Class III recall involves technical or packaging non-conformities that are not expected to cause adverse health consequences. Consult your pharmacist if you have questions.

Official Source Provenance

Verified regulatory citation from U.S. FDA OpenFDA

Primary Data Source: U.S. Food & Drug Administration (FDA) OpenFDA API
Recall Number: D-0343-2026
Questo Retrieval Date: July 31, 2026 14:36 1785508606UTCC
View Official FDA Source

System Notice

Confirm Action