June 2021 FDA Recall Drug by World Source Llc
D-0632-2021 - Subpotent

This Class II drug recall was voluntarily initiated by World Source Llc on June 9, 2021 for the product Drug. The FDA reported the reason for recall as subpotent. The product was distributed in Product was distributed to two hospitals in NY. and the recall is currently terminated.

Recall Number: D-0632-2021

Reason for Recall
Subpotent
Initiated
06-09-2021
Reported
06-23-2021
Quantity
6,300 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
88070
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.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
World Source Llc
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.
Product was distributed to two hospitals in NY.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-09-2022
Product Description About Product Description
Full technical description of the product.
QiYu Hand Sanitizer Gel, ethanol, 500 mL bottles (pump), Manufacturer Guangzhou Minghui Cosmetics Co., Ltd., Baiyun District, Guanzhou

Batch or Lot Expiration Information

Lot# Manufacturer's
Lot# 20200320, exp. date March 2022 WorldSource LLC, Item # TCM004