Eptifibatide Injection, 75 mg/100 mL vial for weight-adjusted bolus dosing, 1x10...
Reason for Recall / Hazard
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.
Product Description & Identification
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 Products
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
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 |
Overview
- Recalling FirmSlate Run Pharmaceuticals
- StatusOngoing
- Risk LevelClass III
- DistributionNationwide within the USA.