AVKARE LLC recalls Tranexamic Acid USP Tablets, 650 mg, 30 tablets (3X10) Unit Dose, Rx Only, Manufactured for: AvKARE Pulaski, TN 38478,…
- Recall date
- June 13, 2023
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0875-2023
- FDA classification
- Class III
- Brand / firm
- AVKARE LLC
- Sold / distributed
- Nationwide in the USA.
Why it was recalled
Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Class III means the product violates regulations but is not likely to cause harm.
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
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