Slate Run Pharmaceuticals Recalls Eptifibatide Injection Due to Labeling Error
Slate Run Pharmaceuticals has issued a voluntary recall for Eptifibatide Injection (75 mg/100 mL) due to a labeling error that misidentifies the product's intended administration method.
What Happened
Slate Run Pharmaceuticals has initiated a voluntary recall of Eptifibatide Injection, 75 mg/100 mL, due to a labeling discrepancy on the product’s carton. The packaging incorrectly states the vial is for “weight-adjusted bolus dosing,” while the FDA-approved statement should read “weight-adjusted infusion.”
Which Products Are Affected
The recall affects all lots within expiry of the following products:
- Product Name: Eptifibatide Injection, 75 mg/100 mL vial
- Slate Run Carton Label: NDC 70436-027-80 (UPC: 0370436027804)
- ProRx Carton Label: NDC 70436-163-80 (UPC: 0370436163809)
- Manufacturer: Hainan Poly Pharm. Co., Ltd.
- Distributor: Slate Run Pharmaceuticals, LLC
This recall applies to distribution nationwide within the United States.
What You Should Do
Healthcare providers and facilities should immediately check their inventory for the affected NDC numbers listed above. If the mislabeled product is found, contact Slate Run Pharmaceuticals for instructions regarding the return or replacement of the vials. Consumers with questions regarding this recall can contact the firm at their Columbus, Ohio headquarters.
Why This Matters
This is classified as a Class III recall, which indicates that the use of or exposure to the mislabeled product is not likely to cause adverse health consequences, but the labeling error represents a regulatory violation.
Source
Information provided by the FDA under Recall Number D-0343-2026.
Source: FDA Official Notice