4e Brands North America Issues Nationwide Voluntary Recall of Hand Sanitizer Due to Potential Presence of Undeclared Methanol (Wood Alcohol)
Ohio Pen/10067087

SAN ANTONIO - OhioPen -- 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):

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

Consumers should contact their physician or healthcare provider if they experienced any problems that may be related to taking or using this product.

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

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