Class III · Low risk
Lysteda (tranexamic acid)
Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Tranexamic Acid USP Tablets
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Cause type: Impurity / degradation
An impurity or degradation product above its limit - other than nitrosamines. Unexpected substances in a batch can make it unsafe or less effective, even when the active ingredient is present. All impurity / degradation recalls.
What was recalled
Tranexamic Acid USP Tablets, 650 mg, 30 tablets (3X10) Unit Dose, Rx Only, Manufactured for: AvKARE Pulaski, TN 38478, NDC 50268-772-13
Affected NDC
50268-0772-13
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 50268-0772 |
650 mg/1 | Tablet Oral |
AvPAK | Rx |
- Recalling firm
- Avkare LLC
- NDC code
- 50268-772-13
- Origin
- TN, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0875-2023 · 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
Tranexamic Acid Injection
Presence of Particulate Matter: Piece of metal found in a vial
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 Avkare LLC
All 2023 recalls
Class II · Moderate risk
Amantadine HCl
Failed Dissolution Specifications: This recall has been initiated due to an Out of Specification finding in dissolution.
Class II · Moderate risk
Rosuvastatin Tablets
Out of specification for dissolution.
Class II · Moderate risk
Norgestimate and Ethinyl Estradiol Tablets
Failed Content Uniformity Specifications
Class II · Moderate risk
chloroproMAZINE Hydrochloride Tablets
Presence of a foreign substance.
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