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
USEptifibatide 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
Recalling Firm: Slate Run Pharmaceuticals
Motivo del Retiro / Peligro
TranslatedLabeling: 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.
Descripción del Producto e Identificación
TranslatedEptifibatide 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
Productos Afectados
TranslatedEptifibatide 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
Additional Source Details
| Field | Value |
|---|---|
| City | Columbus |
| State | OH |
| Openfda › Nui › 1 | N0000008832 |
| Openfda › Nui › 2 | N0000175578 |
| Openfda › Upc › 1 | 0370436027804 |
| Openfda › Upc › 2 | 0370436163809 |
| Openfda › Unii | NA8320J834 |
| Openfda › Route | INTRAVENOUS |
| Openfda › Rxcui › 1 | 200349 |
| Openfda › Rxcui › 2 | 1736470 |
| Openfda › Spl id › 1 | 4a613f2d-85b3-d45c-e063-6294a90adb93 |
| Openfda › Spl id › 2 | 4a614df8-4e1d-d610-e063-6294a90a7d7c |
| Openfda › Brand name | EPTIFIBATIDE |
| Openfda › Spl set id › 1 | da421d88-6c00-428a-82a6-b3b4f7a68b85 |
| Openfda › Spl set id › 2 | 2ab98ecd-c578-4032-a3d5-ae14d58d86a7 |
| Openfda › Package ndc › 1 | 70436-026-80 |
| Openfda › Package ndc › 2 | 70436-027-80 |
| Openfda › Package ndc › 3 | 70436-162-80 |
| Openfda › Package ndc › 4 | 70436-163-80 |
| Openfda › Product ndc › 1 | 70436-026 |
| Openfda › Product ndc › 2 | 70436-027 |
| Openfda › Product ndc › 3 | 70436-162 |
| Openfda › Product ndc › 4 | 70436-163 |
| Openfda › Generic name | EPTIFIBATIDE |
| Openfda › Product type | HUMAN PRESCRIPTION DRUG |
| Openfda › Pharm class pe | Decreased Platelet Aggregation [PE] |
| Openfda › Substance name | EPTIFIBATIDE |
| Openfda › Pharm class epc | Platelet Aggregation Inhibitor [EPC] |
| Openfda › Manufacturer name | Slate Run Pharmaceuticals, LLC |
| Openfda › Application number | ANDA209864 |
| Openfda › Is original packager | true |
| Event id | 98416 |
| Address 1 | 277 W Nationwide Blvd Ste 260 |
| Address 2 | N/A |
| Code info | All lots within expiry |
| Postal code | 43215-0169 |
| Report date | 20260304 |
| Product type | Drugs |
| Product quantity | 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. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260212 |
| Initial firm notification | Letter |
| Center classification date | 20260223 |
Consumer Action Protocol: What You Should Do Immediately
Safety StepsInspect the NDC code, batch number, or control number on your medicine bottle or blister packaging to confirm whether your unit is included.
Do not abruptly stop critical prescribed medication without physician advice. Contact your dispensing pharmacist immediately for a safe alternative.
Under statutory consumer protection rules, consumers are entitled to a full refund, certified replacement, or free repair kit without needing the original sales receipt.
If you suffered an injury, illness, or property damage from this product, file an official incident report with regulatory authorities (FDA Drugs).
Your Legal Rights as a Consumer
Recalls are legally binding corrective safety actions overseen by statutory government bodies. Recalling entities are legally prohibited from charging consumers for official safety remedies. If a retailer or dealership refuses your recall remedy, notify the issuing regulatory agency immediately.
Frequently Asked Questions About This Recall
FAQ GuideQ1:What should I do immediately if I own or bought Eptifibatide Injection, 75 mg/100 mL vial for weight-adjusted bolus dosing, 1x100 mL Single-dose Vial, For Intravenou...?
Check the lot number and NDC on your prescription label. For essential medications, consult your doctor or dispensing pharmacist immediately before abruptly stopping your dose.
Q2:Can I get a full refund or free repair for this recall?
Yes. Recalling manufacturers and retail merchants are required under consumer protection regulations to offer a statutory remedy—typically a full refund, certified repair kit, or replacement unit.
Q3:Do I need my original sales receipt to claim a remedy or refund?
In most recall cases, no receipt is required. Because safety recalls are matters of public health and statutory compliance, retailers and manufacturers routinely issue refunds, store credit, or replacement kits upon presentation of the affected product or lot code.
Q4:Where can I verify official information for this safety alert?
This safety alert is aggregated directly from official regulatory agency records (FDA Drugs). You can click the 'Official Agency Alert' link on this page to view the primary government notice and contact the manufacturer directly.
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Resumen
- Empresa ResponsableSlate Run Pharmaceuticals
- StatusOngoing
- Nivel de RiesgoClass III
- DistributionNationwide within the USA.
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🚨 SAFETY ALERT: Slate Run Pharmaceuticals - 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 if your household is affected: https://therecallfile.com/es/recalls/eptifibatide-injection-75-mg-100-ml-vial-for-weight-adjusted-bolus-dos/FDA-D-0343-2026
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