Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
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.
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
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason Failed Impurities/Degradation Specifications: failed related substance identified as Eptifibatide dimer.
Reason Failed Impurities/Degradation Specifications: Out of Specification (OOS) for known impurity, D-aspartic acid.
Reason Short Fill: fill volume was out of specification at 94 mL (specification: no less than 100 mL) and Failed Impurities/Degradation Specifications: Out…
Reason Failed Impurities/Degradation Specifications: Out of Specification (OOS) for known impurity, D-aspartic acid.
Reason CGMP Deviations
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