QiYu Hand Sanitizer (ethyl alcohol 75% (v/v)), 16.9 FL OZ (500 ML) bottles, Manufactured by: Guangzhou Minghui Cosmetics
Summary
The FDA issued a Class II for QiYu Hand Sanitizer (ethyl alcohol 75% (v/v)), 16.9 FL OZ (500 ML) bottles, Manu by NATIVE PROMOTIONS, INC. Reason: Subpotent.
Details
Source
Drug Recall
External ID
D-0793-2021
Action Date
2021-09-15
Status
Terminated
Category
drug
Product Description
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
Lot/Code Info: Production Batch No.: Q20200510
Quantity Affected: 4,320 bottles
Reason for Recall
Subpotent
Distribution
Tribal nations in the following states: NC, MS, NY, FL, AL, SC, ME, CT, MA, VA, TX, LA, RI
Type: Voluntary: Firm initiated
Recall Initiated: 2021-07-12
Company
Tulsa, OK
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 26 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 (NATIVE PROMOTIONS, INC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does NATIVE PROMOTIONS, INC have FDA actions?
This is the only FDA action we have on record for NATIVE PROMOTIONS, INC in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0793-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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