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D-1551-2022 Class III Ongoing

Recalled by AuroMedics Pharma LLC — East Windsor, NJ

FDA drug recall D-1551-2022 was initiated by AuroMedics Pharma LLC on Sep 26, 2022 and is designated Class III. Reason for recall: Presence of Particulate Matter: Piece of metal found in a vial The recall status is ongoing. Affected quantity: 88080 vials.

Recall Details

Product Type: Drugs
Report Date: Oct 12, 2022
Initiation Date: Sep 26, 2022
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 88080 vials

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

Distribution Pattern

Distributed Nationwide in the USA

Code Information

Lot: CTA210006, Exp. 02/2024

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-1551-2022
openFDA file date: Nov 3, 2026
Loaded by RegDataLab: Nov 4, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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