Class III
Ongoing
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
This recall is currently active, issued October 12, 2022. It was issued by Auromedics Pharma Llc.
- Company
- Auromedics Pharma Llc
- Recall Initiated
- September 26, 2022
- Posted
- October 12, 2022
- Recall Number
- D-1551-2022
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 88080 vials
- Firm Location
- East Windsor, NJ, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Presence of Particulate Matter: Piece of metal found in a vial
Distribution
Distributed Nationwide in the USA
Lot / Code Info
Lot: CTA210006, Exp. 02/2024
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