July 2021 FDA Recall Drug by Native Promotions, Inc
D-0793-2021 - Subpotent
This Class II drug recall was voluntarily initiated by Native Promotions, Inc on July 12, 2021 for the product Drug. The FDA reported the reason for recall as subpotent. The product was distributed in Tribal nations in the following states: NC, MS, NY, FL, AL, SC, ME, CT, MA, VA, TX, LA, RI and the recall is currently terminated.
Recall Number: D-0793-2021
Subpotent
07-12-2021
09-15-2021
4,320 bottles
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
NATIVE PROMOTIONS, INC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Tribal nations in the following states: NC, MS, NY, FL, AL, SC, ME, CT, MA, VA, TX, LA, RI
09-29-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
QiYu Hand Sanitizer (ethyl alcohol 75% (v/v)), 16.9 FL OZ (500 ML) bottles, Manufactured by: Guangzhou Minghui Cosmetics Co., Ltd, Baiyun District, Guanzhou, China Distributed by Native Promotional Products, Tulsa, OK NDC 74447-010
Batch or Lot Expiration Information
Batch# Production Batch No.: Q20200510