Drug Enforcement D-0556-2024

Failed Impurities/Degradation Specifications: failed related substance identified as Eptifibatide dimer.

Status

Ongoing

Classification

Class III

Report Date

June 26, 2024

Termination Date

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Product Information

Product description
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
Product quantity
15,500 single dose vials
Reason for recall
Failed Impurities/Degradation Specifications: failed related substance identified as Eptifibatide dimer.
Recall initiation reason
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Initial firm notification
Letter
Distribution pattern
USA nationwide.

Location & Firm

Recalling firm
Eugia US LLC
Address
279 Princeton Hightstown Rd, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
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Codes & Dates

Recall number
D-0556-2024
Event ID
94680
Recall initiation date
May 22, 2024
Center classification date
June 14, 2024
Code info
Lot #: 3EF22003, Exp 6/30/2025
More code info
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