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

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

When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.

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Summary

Company Announcement Date:
FDA Publish Date:
Product Type:
Drugs
Reason for Announcement:
Recall Reason Description
Undeclared Methanol
Company Name:
4e Brands North America
Brand Name:
Brand Name(s)
Blumen
Product Description:
Product 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 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

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: 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 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 Expanded Release

FDA updates on hand sanitizers consumers should not use


Company Contact Information

Consumers:
4e Brands North America LLC
888-843-0254
4EBrands8797@stericycle.com

Product Photos

 
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