Recall Enforment Report D-1551-2022

Drug Recall Enforcement Report Class III voluntary initiated by AuroMedics Pharma LLC, originally initiated on 09-26-2022 for the product 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 The product was recalled due to presence of particulate matter: piece of metal found in a vial. The product was distributed nationwide and the recall is currently ongoing.

Field Name	Field Value
Event ID	90897 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-1551-2022 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences. What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern	Distributed Nationwide in the USA What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
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
Reason For Recall	Presence of Particulate Matter: Piece of metal found in a vial What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	88080 vials Product Quantity The amount of product subject to recall.
Voluntary Mandated	Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date	10-12-2022
Recall Initiation Date	09-26-2022 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Initial Firm Notification	Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type	Drugs
Recalling Firm	AuroMedics Pharma LLC
Code Info	Lot: CTA210006, Exp. 02/2024 Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Recalled NDC Packages	55150-188-10
Status	Ongoing

Recalled Products