WALGREENS BANDAGES, item number 196568, 110 CT VALUE PACK, 24 BOXES/MASTER (shipping container), Walgreens Family Pack A
Summary
The FDA issued a Class II for WALGREENS BANDAGES, item number 196568, 110 CT VALUE PACK, 24 BOXES/MASTER (ship by ASO LLC. Reason: The adhesive bandage contains 0.1% benzalkonium chloride impregnated in the pad and is not disclosed on the labeling..
Details
Source
Device Recall
External ID
Z-1499-2023
Action Date
2023-05-10
Status
Ongoing
Category
device
Product Description
WALGREENS BANDAGES, item number 196568, 110 CT VALUE PACK, 24 BOXES/MASTER (shipping container), Walgreens Family Pack ASSORTED BANDAGES, 110 ASSORTED SIZES (retail package)
Lot/Code Info: UDI/DI 311917124506; Lot Numbers: 00176259, 00176260, 00176582.
Quantity Affected: 919 cases of 24 units
Reason for Recall
The adhesive bandage contains 0.1% benzalkonium chloride impregnated in the pad and is not disclosed on the labeling.
Distribution
US Nationwide Distribution: IL. FL, CA, CT, OH, TX, IL, SC, and WI
Type: Voluntary: Firm initiated
Recall Initiated: 2023-03-23
Company
Sarasota, FL
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 168 device recalls issued in the same week, part of 403 device-related FDA actions this month.
ASO LLC has 3 FDA actions in our database, including 3 recalls.
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 (ASO LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does ASO LLC have FDA actions?
ASO LLC has 3 FDA actions in our database, including 3 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1499-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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