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
Reported: October 12, 2022 Initiated: September 26, 2022 #D-1551-2022
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
Details
- Recalling Firm
- AuroMedics Pharma LLC
- Units Affected
- 88080 vials
- Distribution
- Distributed Nationwide in the USA
- Location
- East Windsor, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by AuroMedics Pharma LLC. Units affected: 88080 vials.
Why was this product recalled? ▼
Presence of Particulate Matter: Piece of metal found in a vial
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on October 12, 2022. Severity: Low. Recall number: D-1551-2022.
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