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Oder Eaters spray products - recalled due to due to the presence of benzene, USA

2 years ago

United States

Odor-Eaters®, owned by Blistex Inc., is voluntarily recalling a total of forty-one lots of two Odor-Eaters® spray products to the consumer level due to the presence of benzene. Internal testing identified low levels of benzene contamination in specific lots of these aerosol products.

Risk Statement: Benzene is classified as a human carcinogen. Exposure to benzene can occur by inhalation, orally, and through the skin and it can result in cancers including leukemia and blood cancer of the bone marrow and blood disorders which can be life-threatening.

To date, Odor-Eaters® has not received any reports of adverse events related to this recall. The affected Odor-Eaters® spray products are used as antifungal and foot odor-reducing agents and are packaged in aerosol cans. See the link below for UPC, lot number and expiration dates. Refer to the image below for guidance on where to find the lot code details on the can. Forty-one lots of two Odor-Eaters® spray products (Odor-Eaters® Spray Powder and Odor-Eaters® Stink Stoppers® Spray) are impacted by this voluntary recall, specifically the ones listed in the link below.

The products were distributed nationwide in the United States through various retailers. Consumers, distributors, and retailers that have product which is being recalled should stop using or selling these specific Odor-Eaters® spray products and dispose of them appropriately.

Company name: Odor-Eaters®, owned by Blistex Inc.
Brand name: Odor-Eaters®
Product recalled: Oder Eaters spray products
Reason of the recall: Due to the presence of benzene
FDA Recall date: November 17, 2021

Check the full recall details on www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/odor-eatersr-issues-voluntary-nationwide-recall-specific-lots-odor-eatersr-spray-powder-and-odor

Source: FDA

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Risk Statement: Adult patients who are prescribed the maximum daily dose of up to 2 grams per day of Vancomycin Hydrochloride for oral solution, USP 250 mg/5mL, may receive up to 4 grams of oral vancomycin per day because of the overfilled bottle. Some patients with inflammatory disorders of the intestinal mucosa also may have significant systemic absorption of vancomycin. These patients may be at risk for the development of adverse reactions associated with higher doses of vancomycin oral solution. Worsening renal function could be associated with electrolyte abnormalities such as high potassium leading to cardiac arrest.

The recommended maximum daily dose allowance for this product is up to 2gm/day and patients prescribed a dosing regimen of 500 mg/10mL would exceed this daily allowance, which may be harmful to patients with renal insufficiency. The error occurred during the manual bottle filling stage of manufacturing.

Vancomycin Hydrochloride for Oral Solution, USP, 250mg/5mL, is administered orally for treatment of enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains) and antibiotic- associated pseudomembranous colitis caused by C. difficile.

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.
- Pack Size: 150 mL, Expiration Date: 09/2025, Lot: 22613005A, NDC No.: 69238-2261-7.
- 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.

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: Amneal Pharmaceuticals, LLC.
Brand name: Amneal
Product recalled: Vancomycin Hydrochloride for Oral Solution, USP, 250 mg/5mL
Reason of the recall: Super potent due to bottles being overfilled
FDA Recall date: March 27, 2024

Source: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/amneal-pharmaceuticals-llc-issues-nationwide-voluntary-recall-vancomycin-hydrochloride-oral-solution
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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.

Source: recalls-rappels.canada.ca/en/alert-recall/folic-acid-1mg-affected-lots-exceed-or-may-exceed-acceptable-intake-limit-n-nitroso
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Company name: Megadyne Medical Products, Inc.
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Recall link of December 2023: www.jnjmedtech.com/libraries/pdf.js/web/viewer.html?file=/system/files/pdf/mega-soft-reusable-patient-return-electrode-medical-device-correction.pdf#pagemode=none
Source: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/megadyne-reiterates-intended-use-population-change-megadyne-mega-soft-universal-and-universal-plus
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