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

2 years ago

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 fda.gov

Source: FDA

303


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The Vancomycin HCl for Oral Solution, USP, 250 mg/5mL subject to the recall, are identified by the NDC numbers stated on the product label. The following lot numbers of Vancomycin Hydrochloride for Oral Solution, USP, 250 mg/5mL are included in this recall.

Vancomycin Hydrochloride for Oral Solution, USP, 250mg/5mL.
- Pack Size: 80 mL, Expiration Date: 09/2025, Lot: 22613003A, NDC No.: 69238-2261-3.
- Pack Size: 150 mL, Expiration Date: 09/2025, Lot: 22613004A, NDC No.: 69238-2261-7.
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- Pack Size: 300 mL, Expiration Date: 09/2025, Lot: 22613005B, NDC No.: 69238-2261-5.

Anyone with an existing inventory of the product being recalled should examine the product and quarantine any of the recalled lots immediately. Retailers who have Vancomycin Hydrochloride for Oral Solution, USP, 250 mg/5mL, which are being recalled, should examine their inventory and cease dispensing any of the impacted lots.

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Company name: Amneal Pharmaceuticals, LLC.
Brand name: Amneal
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Return affected product to your local pharmacy or place of purchase. Consult your healthcare provider prior to discontinuing use of the affected product(s), or for any health concerns.

If you or a loved one are harmed or experiencing any symptoms, it is important to report it. Reporting can help to detect & resolve outbreaks early and prevent others from being harmed, and enables better surveillance. If symptoms persist, seek medical care.

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