July 2025 FDA Recall Drug by Yangzhou Yulou Paper Products Co., Ltd
D-0659-2025 - cGMP Deviations

This Class II drug recall was voluntarily initiated by Yangzhou Yulou Paper Products Co., Ltd on July 21, 2025 for the product Drug. The FDA reported the reason for recall as cgmp deviations. The product was distributed in N/A and the recall is currently ongoing.

Recall Number: D-0659-2025

Reason for Recall
cGMP Deviations
Initiated
07-21-2025
Reported
10-01-2025
Quantity
500 cases

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
97278
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.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
YANGZHOU YULOU PAPER PRODUCTS CO., LTD
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.
N/A
Product Description About Product Description
Full technical description of the product.
Quick Touch Alcohol Prep Pads(Isopropyl Alcohol 70%), 100 Sterile Pads per carton, AUM Pharmaceuticals, 320 Oser Ave., Hauppauge, NY 11788.

Batch or Lot Expiration Information

Lot# : 20240610, Exp. Date 06/2029