Recall of Blumen Hand Sanitizers
DPHSS and the U.S. Food & Drug Administration (FDA) would like to inform the public of a voluntary recall of ten different bottle sizes of Blumen Hand Sanitizers by 4e Brands North America because of potential presence of undeclared methanol (wood alcohol).
The affected Blumen Hand Sanitizers are packaged in clear plastic bottles with blue caps. The product label contains only blue, white, silver, and red coloring. The lot number is four digits and printed on the bottle. The recalled products are as follows:
The affected Blumen Hand Sanitizers are packaged in clear plastic bottles with blue caps. The product label contains only blue, white, silver, and red coloring. The lot number is four digits and printed on the bottle. The recalled products are as follows:
Product(s) | NDC(s) | SIZE | UPC | LOT |
BLUMEN Advanced Instant Hand Sanitizer Clear | 60599-015-00 | 33.8 fl oz / 1L | 814266023747 | 2213, 2219, 2220, 2221, 2223, 2225, 2252, 2255, 2226, 2227, 2254, 2467, 2244, 2247, 2229, 2845, 2847, 2212, 2217, 2222, 2250, 2249, 2463, 2465, 2676, 2678, 2846, 2216, 2228, 2399, 2464, 2466, 2684, 2246, 2259, 2675, 2683, 2218, 2245, 2231, 2258, 2202, 2215, 2224, 2441, 2251, 2230, 2681, 2256, 2257, 2679, 2682 |
BLUMEN Advanced Hand Sanitizer | 60599-012-04 | 7.5 fl oz/ 221 ml | 814266023624 | 2369, 2440, 2368, 2499, 2439, 2576, 2680, 2744, 2498, 2968, 2497 |
60599-012-08 | 33.8 fl oz / 1L | 814266023693 | 2833, 2748, 2844, 2838, 2775, 2750, 2837, 2839, 2836, 2786, 2905, 2897, 2898, 2907, 2896, 2899, 2906, 2908, 2997, 2372,2894, 2895, 2374, 2373, 2909 | |
BLUMEN Clear LEAR Advanced Hand Sanitizer | 60599 -017-00 | 18 fl oz / 532 ml | 814266023914 | 2910, 2753 |
60599-018-01 | 2 fl oz / 60 ml | 814266023716 | 2234, 2571, 2383 | |
BLUMEN Clear Advanced Hand Sanitizer | 60599-018-02 | 7.5 fl oz / 221 ml | 814266023624 | 2743, 2507, 2459, 2543, 2797, 2799, 2461, 2542, 2800, 2802, 2601, 2361, 2546, 2371, 2544, 2462, 2573, 2574, 2670, 2671,2787, 2891, 2998, 2140, 2265, 2804, 2889, 2438, 2400, 2401, 2382, 2504, 3007, 2128, 2131, 2266, 2365, 2458, 2460, 2773,2512, 2296, 2133, 2352, 2364, 2457, 2545, 2883, 2969, 2268, 2243, 2878, 2363, 2134 |
60599-018-04 | 17 fl oz / 503 ml | 814266024096 | 2263, 2362, 2367, 2780, 2269, 2264, 2741, 2749, 2366, 2745, 2778, 2188, 2293, 2294, 2132, 2135, 2669, 2501, 2673, 2505,2885, 2788, 2877, 2879, 2187, 2130, 2261, 2262, 2600, 2500, 2509, 2515, 2752, 2876, 2351, 2295, 2297, 2575, 2834, 2514,2890, 2129, 2136, 2832, 2506, 2508, 2892, 2911, 2742, 2502, 2503, 2831, 2779, 2511, 2835, 2740, 2776, 2513, 2785, 2516,2267 | |
60599-018-06 | 1.05 GAL / 4L | 814266023686 | 2887, 2888, 2672, 2746, 2510, 2886, 2884, 2602, 2747, 2830, 2777, 2518, 2774, 2801, 2781, 2798, 2784, 2805 | |
60599-018-07 | 3.4 fl oz 100 ml | 814266023594 | 2360, 2370, 2531, 2567, 2141, 2967, 2843, 2880, 2253 | |
BLUMEN Aloe Advanced HandSanitizer, with 70 Alcohol | 60599-028-00 | 3.4 fl oz / 100 ml | 814266023587 | 2369, 2440, 2368 |
The products were distributed nationwide in the United States through retailers and distributors. To date, the Division of Environmental Health of DPHSS has determined that affected Blumen Hand Sanitizers were sold at Benson hardware store in Maite. Benson reported that they received 624 bottles of 7.5 fl. oz. and 480 bottles of 17.0 fl. oz. from an off-island supplier; 183 bottles of 7.5. fl. oz. and 145 bottles of the 17.0 fl. oz. were sold prior to the recall. Benson was notified by their supplier on July 15, 2020 and took corrective actions immediately. All affected products were removed from store shelves.
The Division has not received any local report of injuries or illnesses associated with the use of these recalled commodities. Consumers who have purchased the items listed above are urged to stop using, distributing, or selling these products and return it to the place of purchase.
Substantial methanol exposure could 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 these products and adolescents and adults who drink these products as an alcohol (ethanol) substitute, are most at risk for methanol poisoning.
Consumers should contact their physician or healthcare provider if they experience any problems that may be related to taking or using this product. Questions regarding this recall may be directed to 4e Brands North America LLC by calling 1-888-843-0254 during business hours (Monday-Friday 8 a.m.-5 p.m. EST) or emailing 4EBrands8797@stericycle.com.
For any questions, please contact the Consumer Commodities Program at the Division of Environmental Health at 300-9579.
For the latest information on COVID-19, visit dphss.guam.gov or guamrecovery.com. For inquiries on COVID-19, contact 311 through a local number, or call the Joint Information Center at (671) 478-0208/09/10.
- The Food and Drug Administration is recalling 69 different hand sanitizers due to the presence of methanol in randomized tests.
- Methanol, a type of alcohol, is toxic when ingested and may be harmful when applied directly to the skin.
- Many of the products are manufactured in Mexico and contain expiration dates into 2022, but the agency is continually updating the list below.
[7-2-2020] FDA is warning consumers and health care providers that the agency has seen a sharp increase in hand sanitizer products that are labeled to contain ethanol (also known as ethyl alcohol) but that have tested positive for methanol contamination. Methanol, or wood alcohol, is a substance that can be toxic when absorbed through the skin or ingested and can be life-threatening when ingested.
The agency is aware of adults and children ingesting hand sanitizer products contaminated with methanol that has led to recent adverse events including blindness, hospitalizations and death.
Methanol is not an acceptable active ingredient for hand sanitizers and must not be used due to its toxic effects. FDA’s investigation of methanol in certain hand sanitizers is ongoing. The agency will provide additional information as it becomes available.
Consumers who have been exposed to hand sanitizer containing methanol and are experiencing symptoms should seek immediate treatment for potential reversal of toxic effects of methanol poisoning. 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 for methanol poisoning, young children who accidently ingest these products and adolescents and adults who drink these products as an alcohol (ethanol) substitute, are most at risk.
FDA reminds consumers to wash their hands often with soap and water for at least 20 seconds, especially after going to the bathroom; before eating; and after coughing, sneezing, or blowing one’s nose. If soap and water are not readily available, the Centers for Disease Control and Prevention (CDC) recommend consumers use an alcohol-based hand sanitizer that contains at least 60 percent ethanol (also referred to as ethyl alcohol).
FDA remains vigilant and will continue to take action when quality issues arise with hand sanitizers. The agency is especially concerned with:
- The dangers of drinking any hand sanitizer under any conditions. While hand sanitizers with possible methanol contamination are more life-threatening than those that are not contaminated, FDA urges consumers not to drink any of these products.
- Certain hand sanitizers that may not contain a sufficient amount of ethyl alcohol or isopropyl alcohol.
- Hand sanitizers that are sold or offered for sale with false and misleading, unproven claims that they can prevent the spread of viruses such as COVID-19, including claims that they can provide prolonged protection (e.g., for up to 24-hours).
- Products that are fraudulently marketed as “FDA-approved” since there are no hand sanitizers approved by FDA.
- Products packaged to appear as drinks, candy or liquor bottles, as well as products marketed as drinks or cocktails because their appearance could result in accidental ingestion or encourage ingestion. Children are particularly at risk with these products since ingesting only a small amount of hand sanitizer may be lethal in a young child.
FDA is aware of reports of adverse events associated with hand sanitizer products. FDA encourages health care professionals, consumers and patients to report adverse events or quality problems experienced with the use of hand sanitizers to FDA’s MedWatch Adverse Event Reporting program (please provide the agency with as much information as possible to identify the product):
- Complete and submit the report online; or
- Download and complete the form, then submit it via fax at 1-800-FDA-0178.
FDA’s testing and manufacturer/distributor recalls
The following chart outlines the information on hand sanitizer labels for consumers to use to identify a product:
- That has been tested by FDA and found to contain methanol.
- That is being recalled by the manufacturer or distributor.
- That is purportedly made at the same facility as products that have been tested by FDA and found to contain methanol.
FDA advises consumers not to use hand sanitizers from these companies, or products with these names or NDC numbers.
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