Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1499-2023Class II

WALGREENS BANDAGES, item number 196568, 110 CT VALUE PACK, 24 BOXES/MASTER (shipping container), Walgreens...

Aso LLC / initiated 2023-03-23 / Open, Classified / root cause: manufacturing process

ASO LLC began a recall of WALGREENS BANDAGES, item number 196568, 110 CT VALUE PACK, 24 BOXES/MASTER (shipping container), Walgreens Family Pack ASSORTED BANDAGES, 110 ASSORTED SIZES... on . FDA classified it as Class II and gives the reason as "The adhesive bandage contains 0.1% benzalkonium chloride impregnated in the pad and is not disclosed on the labeling". As of , the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-1499-2023
Classification
Class II
Status
Open, Classified
Initiated
Posted
Recalling firm
Aso LLC
Product
WALGREENS BANDAGES, item number 196568, 110 CT VALUE PACK, 24 BOXES/MASTER (shipping container), Walgreens Family Pack ASSORTED BANDAGES, 110 ASSORTED SIZES (retail package)
Product code
KGX Tape And Bandage, Adhesive
Reason for recall
The adhesive bandage contains 0.1% benzalkonium chloride impregnated in the pad and is not disclosed on the labeling.
Root cause tag
manufacturing process
FDA root cause
Process design
Action
ASO sent an email to the headquarters of its sole consignee on 03/23/2023 to notify them of the intent to recall the product. The notice explained the issue and the risk and requested the return of the product from the retail level.
Quantity in commerce
919 cases of 24 units
Distribution
US Nationwide Distribution: IL. FL, CA, CT, OH, TX, IL, SC, and WI
Product codes and lots
UDI/DI 311917124506; Lot Numbers: 00176259, 00176260, 00176582.

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-1499-2023
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-1499-2023Class IIOngoingVoluntary: Firm initiated