June 2023 FDA Recall Tranexamic Acid by Avkare Llc
D-0875-2023 - Failed Impurities/Degradation Specifications
This Class III drug recall was voluntarily initiated by Avkare Llc on June 13, 2023 for the product Tranexamic Acid. The FDA reported the reason for recall as failed impurities/degradation specifications. The product was distributed Nationwide and the recall is currently ongoing.
Recall Number: D-0875-2023
Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
06-13-2023
06-21-2023
592 cartons
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
AVKARE LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the USA.
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Tranexamic Acid USP Tablets, 650 mg, 30 tablets (3X10) Unit Dose, Rx Only, Manufactured for: AvKARE Pulaski, TN 38478, NDC 50268-772-13
Batch or Lot Expiration Information
Lot# Lot: 44286 Exp. 02/2025
