Tranexamic Acid Injection Recalled Due to Metal Particulate Contamination
AuroMedics Pharma LLC is recalling Tranexamic Acid Injection due to metal particles found in vials. The recalled vials were distributed nationwide; patients should contact their healthcare provider if they have concerns.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This Class III recall involves metal contamination discovered in injectable vials with no reported illnesses or injuries. Given the FDA Class III designation and absence of reported harm, this qualifies as a precautionary recall meriting a Moderate severity rating.
Plain-English summary
AuroMedics Pharma LLC is recalling Tranexamic Acid Injection, USP (1000mg per 10mL) due to the presence of metal particulate matter found in vials. A piece of metal was discovered in one of the recalled vials. The recall affects 88,080 vials of lot CTA210006 with expiration date 02/2024.
The presence of foreign particulate matter in an injectable product poses a potential safety risk to patients. If contaminated vials are administered, the metal particles could cause harm.
The affected product was distributed nationwide in the United States. Healthcare facilities and pharmacies that have received this product should immediately stop distribution and quarantine all affected vials.
Patients who have received injections from affected vials should contact their healthcare provider immediately to report any adverse reactions or concerns. Healthcare providers should monitor patients for any unusual symptoms that may have resulted from injection with this product.
The recalled product
- Product
- TRANEXAMIC ACID (TRANEXAMIC ACID)
- Brand
- TRANEXAMIC ACID
- Manufacturer
- AuroMedics Pharma LLC
- Category
- Drug — Injectable
- Hazard
- metal-contamination
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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