Class III U.S. Food and Drug Administration

Slate Run Pharmaceuticals Eptifibatide Injection recall: Labeling: Not Elsewhere Classified. The carton for Eptifibatide Injection 75

Recall published 8 months ago

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.

The hazard: Drug safety concern

This is an FDA enforcement action. The summary above is the agency’s own description of what went wrong.

What the notice says: 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.

Why it matters: The FDA recorded an enforcement action against this product. The classification and the summary above describe how serious the agency considers it.

Recall details

Recall number
D-0343-2026
Published
March 4, 2026
Risk level
Class III
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Slate Run Pharmaceuticals
Product type
Prescription & OTC drugs
Units affected
N/A
Distribution
Nationwide
Made in
United States
Lot / code info
All lots within expiry

Products covered by this recall

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

Check your product

The notice names 2 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

Package size

Match the net weight or the piece count on the front of the pack.

  • 75 mg
  • 100 mL

Codes are lifted verbatim from the FDA — Drug enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Drug safety

Slate Run Pharmaceuticals — This is an FDA enforcement action. The summary above is the agency’s own description of what went wrong.

  1. Check the lot number on your pack against the codes listed above.
  2. Report side effects you think the product caused to FDA MedWatch.
  3. Do not stop a prescribed medicine on your own — speak to your prescriber or pharmacist first.
  4. Ask the dispensing pharmacy for a replacement from an unaffected lot.

Refunds and replacements

With medicines, a replacement supply matters more than cash, and that is what pharmacies are set up to provide.

  • Ask the dispensing pharmacy for a like-for-like replacement from an unaffected lot. This is the fastest route and usually costs nothing.
  • For a mail-order or online pharmacy, use the recall line listed on this page rather than the general support queue.
  • If the recall voided a fill you had already paid for, your insurer will normally authorise a replacement ahead of schedule. Quote the recall number.
  • If you paid out of pocket, ask for a refund of the co-pay or purchase price and keep the receipt the pharmacy issues.

Company contact: Slate Run Pharmaceuticals — 277 W Nationwide Blvd Ste 260, Columbus, OH, 43215-0169

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Drug enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Slate Run Pharmaceuticals prescription & otc drugs recalled?

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. 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.

How do I know if I have the recalled product?

The notice does not publish package codes for this recall. Compare the product name, size and the purchase window against the official FDA — Drug enforcement record, and contact the company if you are unsure.

What should I do with it right now?

Check the lot number on your pack against the codes listed above.

Can I get my money back?

Ask the dispensing pharmacy for a like-for-like replacement from an unaffected lot. This is the fastest route and usually costs nothing.

Where was the recalled product sold?

It was distributed nationwide.

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