FDA Recall D-1551-2022
AuroMedics Pharma LLC · East Windsor, NJ
Class III Ongoing 1326 days on record
Lower impact — Class III recall — product violates FDA labeling or manufacturing standards but is unlikely to cause adverse health consequences.
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
Reason for recall
Presence of Particulate Matter: Piece of metal found in a vial
Recall record
- Recall number
D-1551-2022- Classification
- Class III
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Distributed Nationwide in the USA
- Recall initiated
- 2022-09-26
- Classified by FDA Center
- 2022-09-30
- FDA published
- 2022-10-12
- Recalling firm
- AuroMedics Pharma LLC
- Firm location
- East Windsor, NJ
Drug identification
- Brand name(s)
- TRANEXAMIC ACID
- Generic name(s)
- TRANEXAMIC ACID
- Manufacturer(s)
- Eugia US LLC
- NDC(s)
55150-188- Route(s)
- INTRAVENOUS
Operational response
Class III recalls are unlikely to cause adverse health consequences but indicate a violation of FDA labeling or manufacturing standards. Pull from active dispensing per your operational policy.
For the official FDA enforcement record, see FDA's Recall Search.