Tranexamic Acid Injection Recalled for Metal Particulate Matter
AuroMedics Pharma LLC is recalling one lot of Tranexamic Acid Injection due to the presence of metal particles found in a vial. The affected product was distributed nationwide.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: This is an FDA Class III recall. The source text reports a defect (metal particulate matter in a vial) but does not report any illnesses, injuries, or confirmed adverse events. Class III recalls are by definition unlikely to cause adverse health consequences, placing this at the low end of the severity scale.
Plain-English summary
AuroMedics Pharma LLC is recalling Tranexamic Acid Injection, USP, 1000 mg per 10 mL (100 mg/mL) in 10 mL single-dose vials distributed nationwide in the USA. The recall affects lot CTA210006 (expiration 02/2024), comprising 88,080 vials.
The product is being recalled because a piece of metal was found in a vial. Tranexamic Acid Injection is a prescription intravenous medication used to decrease fibrinolysis. The presence of particulate matter in an injectable product poses a potential safety risk to patients who receive the affected medication.
Patients or healthcare providers who have received or are currently using this lot should stop using it and consult with their healthcare provider. The product was manufactured in India and distributed by AuroMedics Pharma LLC, E. Windsor, NJ 08520. Patients with questions about this recall should contact their healthcare provider or AuroMedics Pharma LLC.
The recalled product
- Product
- TRANEXAMIC ACID (TRANEXAMIC ACID)
- Brand
- TRANEXAMIC ACID
- Manufacturer
- AuroMedics Pharma LLC
- Category
- Drug — Intravenous Injection
- Affected units
- 88,080
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot: CTA210006
- Exp. 02/2024
UPCs (1)
- 0355150188109
Distribution
Distributed nationwide across the United States.
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