Class III · Low risk
Eptifibatide injection 20mg/10mL
Failed Impurities/Degradation Specifications: failed related substance identified as Eptifibatide dimer.
Eptifibatide Injection
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was 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.
Cause type: Labeling / mix-up
Wrong label, wrong strength, mixed-up products, or packaging errors. One of the most dangerous causes - you can end up taking the wrong drug or the wrong dose. All labeling / mix-up recalls.
What was recalled
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
Affected NDCs
70436-0027-80
70436-0163-80
Compare with the code on your package — it is the most precise check available.
Drug: Eptifibatide
Product details
From the FDA NDC directory, for the product codes this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Eptifibatide NDC 70436-0027 |
.75 mg/mL | Injection Intravenous |
Slate Run Pharmaceuticals, LLC | Rx |
| Eptifibatide NDC 70436-0163 |
.75 mg/mL | Injection Intravenous |
Slate Run Pharmaceuticals, LLC | Rx |
- Recalling firm
- Slate Run Pharmaceuticals
- Origin
- OH, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0343-2026 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm.
Other Eptifibatide recalls
See all
Class III · Low risk
Eptifibatide Injection
Failed Impurities/Degradation Specifications: Out of Specification (OOS) for known impurity, D-aspartic acid.
Class III · Low risk
Eptifibatide Injection
Short Fill: fill volume was out of specification at 94 mL (specification: no less than 100 mL) and Failed Impurities/Degradation Specifications: Out of Specification (OOS) for known impurity, D-aspartic acid.
Class III · Low risk
Eptifibatide Injection
Failed Impurities/Degradation Specifications: Out of Specification (OOS) for known impurity, D-aspartic acid.
Class II · Moderate risk
Eptifibatide Injection 75 mg/100 mL
CGMP Deviations
Other recalls by Slate Run Pharmaceuticals
All 2026 recalls
Class II · Moderate risk
Cinacalcet Hydrochloride Tablets 60 mg
CGMP deviations: The presence of nitrosamine impurity above the acceptable daily intake limits.
Class II · Moderate risk
Cinacalcet Hydrochloride Tablets 30 mg
CGMP deviations: The presence of nitrosamine impurity above the acceptable daily intake limits.
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