AuroMedics Pharma LLC: Drug Recall
Recall #D-1551-2022 · 09/26/2022
Class III: Low Risk
Recall Details
- Recall Number
- D-1551-2022
- Classification
- Class III
- Product Type
- Drug
- Recalling Firm
- AuroMedics Pharma LLC
- Status
- Ongoing
- Date Initiated
- 09/26/2022
- Location
- East Windsor, NJ, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 88080 vials
Reason for Recall
Presence of Particulate Matter: Piece of metal found in a vial
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
Distribution Pattern
Distributed Nationwide in the USA
Other Recalls by AuroMedics Pharma LLC
- Class II: Risk 09/30/2022
- Class II: Risk 09/26/2022
- Class I: Dangerous 01/26/2022
- Class II: Risk 12/30/2020
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.