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

Published 14 July 2020

Buckie Got It, St. Kitts and Nevis News Source

Summary

Company Announcement Date:July 11, 2020FDA Publish Date:July 13, 2020Product Type:DrugsReason for Announcement:Undeclared MethanolCompany Name:4e Brands North AmericaBrand Name:BlumenProduct Description:Hand Sanitizer

Company Announcement

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	814266023096	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	2226	2267	2400	2510	2678	2787	2885
2129	2227	2268	2401	2512	2679	2788	2886
2130	2228	2269	2438	2513	2680	2797	2887
2131	2229	2293	2439	2514	2681	2799	2888
2132	2230	2294	2440	2515	2682	2801	2889
2133	2234	2295	2441	2518	2683	2804	2890
2134	2243	2296	2457	2531	2684	2805	2891
2135	2244	2297	2458	2542	2740	2830	2892
2136	2245	2351	2459	2543	2741	2832	2894
2140	2246	2352	2460	2544	2743	2833	2895
2141	2247	2360	2461	2546	2744	2834	2896
2187	2249	2361	2462	2567	2746	2835	2897
2188	2250	2362	2463	2571	2747	2836	2898
2202	2251	2363	2464	2573	2748	2837	2899
2212	2252	2364	2465	2574	2749	2838	2905
2213	2253	2365	2466	2575	2750	2839	2906
2215	2254	2366	2467	2576	2752	2843	2907
2216	2255	2367	2497	2600	2753	2844	2908
2217	2256	2368	2499	2601	2773	2845	2909
2218	2257	2369	2500	2602	2774	2846	2910
2219	2259	2370	2501	2669	2775	2847	2911
2220	2261	2371	2504	2670	2776	2876	2969
2221	2262	2372	2505	2671	2777	2877	2998
2222	2263	2374	2506	2672	2780	2878	3007
2223	2264	2382	2507	2673	2781	2879
2224	2265	2383	2508	2675	2784	2880
2225	2266	2399	2509	2676	2785	2884

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.

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: [email protected] 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 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.

Complete and submit the report Online
Regular Mail or Fax: Download form 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.

Link to CDER Release