AuroMedics Pharma LLC is recalling 88,080 vials of Tranexamic Acid Injection, USP (1,000 mg per 10 mL) because a piece of metal was found inside a vial. The recall affects lot CTA210006 with an expiration date of February 2024. This prescription medication is a sterile injectable solution distributed nationwide to hospitals and healthcare facilities.
Injecting a drug containing metal particulate matter can cause serious health complications, including local irritation, inflammation, or the blockage of blood vessels, which may lead to organ damage or other life-threatening events.
Manufacturer return
Distributed by AuroMedics Pharma LLC, E. Windsor, NJ 08520.
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Sources: FDA iRES · Raw API Response
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