Class III · Low risk
Tranexamic Acid USP Tablets
Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Tranexamic Acid Injection
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Presence of Particulate Matter: Piece of metal found in a vial
Cause type: Particulate / foreign matter
Visible foreign particles - glass, metal, fibers or other material - found in the product. Particles can enter from equipment wear, containers or the process, and are dangerous in injectables. All particulate / foreign matter recalls.
What 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
Affected NDC
55150-0188-10
Compare with the code on your package — it is the most precise check available.
Drug: Tranexamic
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Tranexamic Acid NDC 55150-0188 |
100 mg/mL | Injection, Solution Intravenous |
Eugia US LLC | Rx |
- Recalling firm
- AuroMedics Pharma LLC
- NDC code
- 55150-188-10
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1551-2022 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm.
Other Tranexamic recalls
See all
Class III · Low risk
Lysteda (tranexamic acid)
Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Class I · High risk
Tranexamic Acid Injection
Labeling: Label Mix-Up; potential for cartons labeled as Tranexamic Acid Injection, USP to contain vials of Amiodarone HCl Injection, USP and cartons labeled as Amiodarone HCl Injection, USP to contain vials of Tranexamic Acid Injection, USP.
Class II · Moderate risk
Tranexamic Acid active pharmaceutical ingredient packaged in…
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Class II · Moderate risk
Tranexamic Acid Injection USP
Presence of Particulate Matter: Particulate matter consistent with delamination of the glass vial container.
Other recalls by AuroMedics Pharma LLC
All 2022 recalls
Class II · Moderate risk
Fondaparinux Sodium Injection
Subpotent Drug: Out of specification for assay
Class II · Moderate risk
Acyclovir Sodium Injection
Presence of Particulate Matter: Customer complaint for a dark red, brown and black particulate floating inside vial.
Class I · High risk
Polymyxin B for Injection USP
Presence of Particulate Matter; product complaint of hair discovered in a vial within the lot
Class II · Moderate risk
Acetaminophen Injection 1
Discoloration and failed pH specifications
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