Tranexamic Acid Injection, USP, 1000mg per 10 mL (100mg /mL), 10mL single-dose vial, Rx Only, Distributed by: AuroMedics
Summary
The FDA issued a Class III for Tranexamic Acid Injection, USP, 1000mg per 10 mL (100mg /mL), 10mL single-dose v by AuroMedics Pharma LLC. Reason: Presence of Particulate Matter: Piece of metal found in a vial.
Details
Source
Drug Recall
External ID
D-1551-2022
Action Date
2022-10-12
Status
Ongoing
Category
drug
Product Description
Tranexamic Acid Injection, USP, 1000mg per 10 mL (100mg /mL), 10mL single-dose vial, Rx Only, Distributed by: AuroMedics Pharma LLC E. Windsor, NJ 08520, Made in India, NDC 55150-188-10
Lot/Code Info: Lot: CTA210006, Exp. 02/2024
Quantity Affected: 88080 vials
Reason for Recall
Presence of Particulate Matter: Piece of metal found in a vial
Distribution
Distributed Nationwide in the USA
Type: Voluntary: Firm initiated
Recall Initiated: 2022-09-26
Company
East Windsor, NJ
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 33 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
AuroMedics Pharma LLC has 4 FDA actions in our database, including 4 recalls.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (AuroMedics Pharma LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does AuroMedics Pharma LLC have FDA actions?
AuroMedics Pharma LLC has 4 FDA actions in our database, including 4 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-1551-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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