Eptifibatide Injection, 75 mg/100 mL vial for weight-adjusted bolus dosing, 1x100 mL Single-dose Vial, For Intravenous U
Summary
The FDA issued a Class III for Eptifibatide Injection, 75 mg/100 mL vial for weight-adjusted bolus dosing, 1x10 by Slate Run Pharmaceuticals. 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 .
Details
Source
Drug Recall
External ID
D-0343-2026
Action Date
2026-03-04
Status
Ongoing
Category
drug
Product Description
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
Lot/Code Info: All lots within expiry
Quantity Affected: N/A
Reason for Recall
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.
Distribution
Nationwide within the USA.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-02-12
Company
Columbus, OH
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 39 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Slate Run Pharmaceuticals has 3 FDA actions in our database, including 3 recalls.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Slate Run Pharmaceuticals) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Slate Run Pharmaceuticals have FDA actions?
Slate Run Pharmaceuticals has 3 FDA actions in our database, including 3 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0343-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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