Drug Enforcement D-0389-2025

Out-of-Specification test results were obtained in at long term conditions during 3 month's stability study for related substances.

Status

Ongoing

Classification

Class II

Report Date

May 7, 2025

Termination Date

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Product Information

Product description
Tirofiban Hydrochloride Injection 5 mg/100 mL (50 mcg/mL), 100 mL single-dose container (bag), Rx only, Manufactured in India for: Eugia U.S. LLC, 279 Princeton-Hightstown Rd., E. Windsor, NJ 08520, NDC 55150-429-01
Product quantity
18,867 bags
Reason for recall
Out-of-Specification test results were obtained in at long term conditions during 3 month's stability study for related substances.
Recall initiation reason
—
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
—

Codes & Dates

Recall number
D-0389-2025
Event ID
96718
Recall initiation date
April 21, 2025
Center classification date
April 25, 2025
Code info
Lot #: 3TF24002A, Exp 11/30/2026
More code info
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