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4e Brands North America Issues Nationwide Voluntary Recall of Hand Sanitizer Due to Potential Presence of Undeclared Methanol (Wood Alcohol)
EntSun News/10829934
SAN ANTONIO - EntSun -- San Antonio, Texas, 4e Brands North America is voluntarily recalling ten (10) bottle sizes of Hand Sanitizers to the consumer level. The products are being recalled due to the potential presence of methanol (wood alcohol).
Risk Statement: 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. To date, 4e Brands North America has not received reports of adverse events related to this recall.
Recalled Products
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 Hand Sanitizers are packaged in clear plastic bottles. The recalled products are as follows (a full listing of lot numbers in numerical order is included below the chart):
LOT NUMBERS
The Hand Sanitizer is in a clear bottle with a blue cap. The product label contains only blue, white, silver, and red coloring. The lot number is four digits and printed on the bottle.
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The product was distributed nationwide in the United States through retailers and distributors.
4e Brands North America is notifying its distributors and retailers by recall letter and consumers via this press release. 4e Brands North America is arranging for the return and refund of all recalled products.
Consumers/distributors/retailers that have the product subject to this recall should stop using/distributing/selling Hand Sanitizer and return it to the place of purchase.
Consumers with questions regarding this recall can contact 4e Brands North America LLC during business hours: Monday - Friday 08:00 am - 5:00 pm EST at:
Adverse reactions from use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
Risk Statement: 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. To date, 4e Brands North America has not received reports of adverse events related to this recall.
Recalled Products
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 Hand Sanitizers are packaged in clear plastic bottles. The recalled products are as follows (a full listing of lot numbers in numerical order is included below the chart):
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 Hand Sanitizer, with 70 Alcohol | 60599-028-00 | 3.4 fl oz / 100 ml | 814266023587 | 2369, 2440, 2368 |
LOT NUMBERS
2128 | 2229 | 2294 | 2457 | 2516 | 2684 | 2799 | 2887 |
2129 | 2230 | 2295 | 2458 | 2518 | 2740 | 2800 | 2888 |
2130 | 2231 | 2296 | 2459 | 2531 | 2741 | 2801 | 2889 |
2131 | 2234 | 2297 | 2460 | 2542 | 2742 | 2802 | 2890 |
2132 | 2243 | 2351 | 2461 | 2543 | 2743 | 2804 | 2891 |
2133 | 2244 | 2352 | 2462 | 2544 | 2744 | 2805 | 2892 |
2134 | 2245 | 2360 | 2463 | 2545 | 2745 | 2830 | 2894 |
2135 | 2246 | 2361 | 2464 | 2546 | 2746 | 2831 | 2895 |
2136 | 2247 | 2362 | 2465 | 2567 | 2747 | 2832 | 2896 |
2140 | 2249 | 2363 | 2466 | 2571 | 2748 | 2833 | 2897 |
2141 | 2250 | 2364 | 2467 | 2573 | 2749 | 2834 | 2898 |
2187 | 2251 | 2365 | 2497 | 2574 | 2750 | 2835 | 2899 |
2188 | 2252 | 2366 | 2498 | 2575 | 2752 | 2836 | 2905 |
2202 | 2253 | 2367 | 2499 | 2576 | 2759 | 2837 | 2906 |
2212 | 2254 | 2368 | 2500 | 2600 | 2773 | 2838 | 2907 |
2213 | 2255 | 2369 | 2501 | 2601 | 2774 | 2839 | 2908 |
2215 | 2256 | 2370 | 2502 | 2602 | 2775 | 2843 | 2909 |
2216 | 2257 | 2371 | 2503 | 2669 | 2776 | 2844 | 2910 |
2217 | 2258 | 2372 | 2504 | 2670 | 2777 | 2845 | 2911 |
2218 | 2259 | 2373 | 2505 | 2671 | 2778 | 2846 | 2967 |
2219 | 2261 | 2374 | 2506 | 2672 | 2779 | 2847 | 2968 |
2220 | 2262 | 2382 | 2507 | 2673 | 2780 | 2876 | 2969 |
2221 | 2263 | 2383 | 2508 | 2675 | 2781 | 2877 | 2997 |
2222 | 2264 | 2399 | 2509 | 2676 | 2784 | 2878 | 2998 |
2223 | 2265 | 2400 | 2510 | 2678 | 2785 | 2879 | 3007 |
2224 | 2266 | 2401 | 2511 | 2679 | 2786 | 2880 | |
2225 | 2267 | 2438 | 2512 | 2680 | 2787 | 2883 |
2226 | 2268 | 2439 | 2513 | 2681 | 2788 | 2884 | |
2227 | 2269 | 2440 | 2514 | 2682 | 2797 | 2885 | |
2228 | 2293 | 2441 | 2515 | 2683 | 2798 | 2886 |
The Hand Sanitizer is in a clear bottle with a blue cap. The product label contains only blue, white, silver, and red coloring. The lot number is four digits and printed on the bottle.
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The product was distributed nationwide in the United States through retailers and distributors.
4e Brands North America is notifying its distributors and retailers by recall letter and consumers via this press release. 4e Brands North America is arranging for the return and refund of all recalled products.
Consumers/distributors/retailers that have the product subject to this recall should stop using/distributing/selling Hand Sanitizer and return it to the place of purchase.
Consumers with questions regarding this recall can contact 4e Brands North America LLC during business hours: Monday - Friday 08:00 am - 5:00 pm EST at:
- Toll Free: 888-843-0254
- FAX: 888-214-7430
- Email: 4EBrands8797@stericycle.com
- Event 8797
Adverse reactions from use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call
- 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA- 0178
Contact
4e Brands North America
Mon-Fri 8am-5pm CDT
Toll Free: 888-843-0254, FAX: 888-214-7430
4ebrands8797@stericycle.com
4e Brands North America
Mon-Fri 8am-5pm CDT
Toll Free: 888-843-0254, FAX: 888-214-7430
4ebrands8797@stericycle.com
Source: 4e Brands North America
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