Scented Hand Sanitizer - recalled due to Methanol, Benzene and Acetaldehyde, USA

2 years ago source www.fda.gov

Recall notice

United States

Company name: Scentsational Soaps & Candles, Inc.
Brand name: Ulta Beauty Collection & SS
Product recalled: Scented Hand Sanitizer
Reason of the recall: Presence of Methanol (Wood Alcohol), Benzene and Acetaldehyde
FDA Recall date: April 28, 2021
Recall details: Scentsational Soaps & Candles, Inc., is voluntarily recalling 5 lots of Scentsational Soaps & Candles scented Hand Sanitizers from the Black and White Collection and Photo Real Collection and 3 lots of Ulta Beauty Collection scented Hand Sanitizer Spray packaged in 3.38 and 3.4 fluid ounce spray bottles, respectively, to the consumer level. See products listed in the table below.

These products are being recalled after testing conducted by our firm revealed the presence of methanol (wood alcohol), benzene, and acetaldehyde. These products were distributed nationwide in the USA through Ulta Beauty, TJ Maxx, and Marshalls retail stores.

Risk Statement: Substantial methanol exposure can result in nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma, permanent damage to the nervous system, or death. Although all persons using these products on their hands are at risk, young children who accidentally ingest the products and adolescents and adults who drink the products as an alcohol (ethanol) substitute are most at risk for methanol poisoning. Exposure to benzene can occur through inhalation, oral, and skin.

There is a reasonable probability that benzene present at levels above the maximum daily exposure recommendations can result in cancers including leukemia and blood cancer of the bone marrow and blood disorders which can be life-threatening. Additionally, animal studies have shown that acetaldehyde can possibly cause cancer in humans.

To date, the company has not received any reports of adverse reactions related to this recall. These products are used as hand sanitizers and marketed to help decrease bacteria on the skin when soap and water are not available. The affected bottles of hand sanitizer include a five-digit lot code printed on the bottle near the base or, in the case of the Ulta Beauty Collection product, a five-digit lot code followed by a single letter. The products can be identified by the label, scent, and lot code provided in the table at the end of this release. Photos are also attached to this notice.

Scentsational Soaps & Candles, Inc., has notified its direct customers by telephone with confirmatory email and asked that they remove the recalled products from commerce immediately if they still had any in inventory. Consumers, distributors and retailers that have the hand sanitizers which are being recalled should stop using, distributing and/or selling them and return them to the place of purchase.

Ulta Beauty has confirmed it has removed the recalled Ulta Beauty Collection product from its stores and online. Consumers with questions regarding this recall can contact our Customer Support Desk, 1-855-554-8050, M-F, during business hours 9:00 a.m. – 5:00 p.m. ET.

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online by regular mail or by fax.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration. “As the owners of the company, my wife and I want to reassure consumers and our customers that we are doing absolutely everything possible to carry out this recall efficiently and effectively and ensure it does not happen again.” said Steve Morrison of Scentsational Soaps & Candles, Inc.

Check the full recall details on www.fda.gov

Source: FDA

#drugs #blood #us

Recent Interesting Reports

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Scam, Summit Avenue, Union City, NJ, USA

4 weeks ago reported by user-fghvp525

I bought an item from this company and they sent the order and the cord does not fit, so I'm unable to use it. I paid through PayPal so I'm going to try and get my money back.

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Cash Giraffe Scam, online

1 week ago reported by user-kqcxq168

I have been using Cash App Giraffe games for some time now as they have been touted on many websites and articles as a great way to earn extra cash by just playing games.
IT IS A LIE!
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games and when you try to redeem the points you have earned the "certificates" or "certificate numbers" DO NOT WORK!
When I tried to contact customer service, several times, they do not even reply! They will send you a confirmation email saying a ticket has been opened but then you hear NOTHING. I'm furious because this is being presented on many levels as a supposed way to earn extra cash, even on articles about retired ways to earn money.
THIS IS A SCAM! They will get you to spend money to play the games thinking that you will earn more than you spend but you will NOT and NO ONE will answer questions at all.
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Z
The absolute worst! Product faulty- mis representation and no resolution offered for $50+ dollars spent with pictures of proof and the “best” resolution was $5 is dollars. How is a $5 refund a solution for $50 and an unusable product.

The absolute worst online service and product ever!

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AvKARE, LLC. is voluntarily recalling lot # AW0221A of Atovaquone Oral Suspension, USP 750mg/5mL to the Consumer/User level, due to the potential Bacillus cereus contamination in the product found during stability testing at a 3rd party lab. Atovaquone Oral Suspension, USP was distributed between 03/18/2024 through 03/21/2024 … See More
Nationwide to Wholesalers. To date, AvKARE has not received any reports of adverse events related to this recall.

Risk Statement: In the population most at risk, immunocompromised population, there is a reasonable probability that microbial contamination of Atovaquone Oral Suspension can result in disseminated, life threatening infections such as endocarditis and necrotizing soft tissue infections.

Atovaquone Oral Suspension, USP is indicated for prevention and treatment of Pneumocystis jiroveci pneumonia (PCP) in adults and children 13 years of age and older who cannot tolerate other medicines, such as trimethoprim-sulfamethoxazole.

The product is packaged in a carton. The identified NDC # associated with the product is 50268-086-12, UPC # 5026808612 and the affected lot# is AW0221A with an expiration date of 08/2025.

AvKARE, LLC is notifying its distributors and wholesale customers by mailings and email communications method and is arranging for returns of all recalled Atovaquone Oral Suspension, USP. Wholesalers who have Atovaquone Oral Suspension, USP 750mg/5mL, which are being recalled, should examine their inventory and cease dispensing, return any of the impacted lots to AvKARE, LLC. Consumers that have product which is being recalled should stop using the product and return it to place of purchase.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.  

In case you experience harm from this product, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance. If symptoms persist, seek medical care.

Company name: AvKARE, LLC
Brand name: AVpak
Product recalled: Atovaquone Oral Suspension, USP 750mg/5mL
Reason of the recall: Potential Bacillus cereus contamination
FDA Recall date: April 01, 2024

Source: www.fda.gov
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#drugs #us

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