May 2024 FDA Recall Eptifibatide by Eugia Us Llc
D-0556-2024 - Failed Impurities/Degradation Specifications
This Class III drug recall was voluntarily initiated by Eugia Us Llc on May 22, 2024 for the product Eptifibatide. The FDA reported the reason for recall as failed impurities/degradation specifications. The product was distributed Nationwide and the recall is currently ongoing.
Recall Number: D-0556-2024
Failed Impurities/Degradation Specifications: failed related substance identified as Eptifibatide dimer.
05-22-2024
06-26-2024
15,500 single dose vials
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Eugia US LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
USA nationwide.
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Eptifibatide injection 20mg/10mL (2mg/mL), 10mL Single-Dose Vial, Rx only, Mfd. In India for: AuroMedics Pharma, LLC, E. Windsor, NJ 08520, NDC 55150-219-10
Batch or Lot Expiration Information
Lot# : 3EF22003, Exp 6/30/2025
