Drug Enforcement D-1551-2022

Presence of Particulate Matter: Piece of metal found in a vial

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Status

Ongoing

Classification

Class III

Report Date

October 12, 2022

Termination Date

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Product Information

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
Product quantity
88080 vials
Reason for recall
Presence of Particulate Matter: Piece of metal found in a vial
Recall initiation reason
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Initial firm notification
Letter
Distribution pattern
Distributed Nationwide in the USA

Location & Firm

Recalling firm
AuroMedics Pharma LLC
Address
279 Princeton Hightstown Rd, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
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Codes & Dates

Recall number
D-1551-2022
Event ID
90897
Recall initiation date
September 26, 2022
Center classification date
September 30, 2022
Code info
Lot: CTA210006, Exp. 02/2024
More code info
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