Betadine Solution Swabstick Povidone-Iodine Solution USP, 10 % single and three count Antispetic Non-Sterile Solution
Summary
The FDA issued a Class II for Betadine Solution Swabstick Povidone-Iodine Solution USP, 10 % single and three by AVRIO HEALTH L.P. Reason: Subpotent Drug.
Details
Source
Drug Recall
External ID
D-0828-2021
Action Date
2021-09-29
Status
Terminated
Category
drug
Product Description
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
Lot/Code Info: 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
Quantity Affected: 75,828 shippers
Reason for Recall
Subpotent Drug
Distribution
Product was distributed nationwide.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-08-26
Company
Stamford, CT
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 42 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (AVRIO HEALTH L.P) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does AVRIO HEALTH L.P have FDA actions?
This is the only FDA action we have on record for AVRIO HEALTH L.P in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0828-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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