FDA Recall D-0389-2025

Eugia US LLC · East Windsor, NJ

Class II Ongoing 388 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

Product

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

Lot / code: Lot #: 3TF24002A, Exp 11/30/2026

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 record

Recall number: D-0389-2025
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: USA nationwide.
Recall initiated: 2025-04-21
Classified by FDA Center: 2025-04-25
FDA published: 2025-05-07
Recalling firm: Eugia US LLC
Firm location: East Windsor, NJ

Drug identification

Brand name(s): TIROFIBAN
Generic name(s): TIROFIBAN
Manufacturer(s): Eugia US LLC
NDC(s): 55150-429, 55150-430
Route(s): INTRAVENOUS

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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