August 2021 FDA Recall Betadine by Avrio Health L.p
D-0828-2021 - Subpotent Drug

This Class II drug recall was voluntarily initiated by Avrio Health L.p on August 26, 2021 for the product Betadine. The FDA reported the reason for recall as subpotent drug. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0828-2021

Reason for Recall
Subpotent Drug
Initiated
08-26-2021
Reported
09-29-2021
Quantity
75,828 shippers

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
88539
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
AVRIO HEALTH L.P
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product was distributed nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-12-2023
Product Description About Product Description
Full technical description of the product.
Betadine Solution Swabstick Povidone-Iodine Solution USP, 10 % single and three count Antispetic Non-Sterile Solution Avrio Health LP Stamford, CT 06901-3431 NDC 67618-153-01, NDC 67618-153-03

Batch or Lot Expiration Information

Lot# 11901232, Exp. Date 09/30/2021 11901549, Exp. Date 11/30/2021 12000585, Exp. Date 03/31/2022 12000964, Exp. Date 5/31/2022 12001457, Exp. Date 7/31/2022 12002142, Exp. Date 12/31/2022 12100407, Exp. Date 03/31/2023 11901231, Exp. Date 09/30/2021 11901548, Exp. Date 11/30/2021 12000584, Exp. Date 03/31/2022 12000963, Exp. Date 05/31/2022 12001185, Exp. Date 06/30/2022 12001456, Exp. Date 07/31/2022 12002150, Exp. Date 12/31/2022 12100406, Exp. Date 03/31/2023

Affected Packages Involved in this Recall

67618-153-01 Betadine Solution Swabsticks
67618-153-03 Betadine Solution Swabsticks