Quick Touch Alcohol Prep Pads(Isopropyl Alcohol 70%), 100 Sterile Pads per carton, AUM Pharmaceuticals, 320 Oser Ave., H
Summary
The FDA issued a Class II for Quick Touch Alcohol Prep Pads(Isopropyl Alcohol 70%), 100 Sterile Pads per carto by YANGZHOU YULOU PAPER PRODUCTS CO., LTD. Reason: cGMP Deviations.
Details
Source
Drug Recall
External ID
D-0659-2025
Action Date
2025-10-01
Status
Ongoing
Category
drug
Product Description
Quick Touch Alcohol Prep Pads(Isopropyl Alcohol 70%), 100 Sterile Pads per carton, AUM Pharmaceuticals, 320 Oser Ave., Hauppauge, NY 11788.
Lot/Code Info: Lot #: 20240610, Exp. Date 06/2029
Quantity Affected: 500 cases
Reason for Recall
cGMP Deviations
Distribution
N/A
Type: Voluntary: Firm initiated
Recall Initiated: 2025-07-21
Company
Yangzhou, N/A
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 70 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 (YANGZHOU YULOU PAPER PRODUCTS CO., LTD) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does YANGZHOU YULOU PAPER PRODUCTS CO., LTD have FDA actions?
This is the only FDA action we have on record for YANGZHOU YULOU PAPER PRODUCTS CO., LTD in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0659-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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