Category: Drugs

Summary

Company Announcement Date:
FDA Publish Date:
Product Type:
Drugs
Reason for Announcement:
Undeclared Methanol
Company Name:
4e Brands North America
Brand Name:
Assured, Blumen, Modesa
Product Description:
Hand Sanitizer

Company Announcement

San Antonio, Texas, 4e Brands North America is voluntarily recalling all lots of Hand Sanitizer brands to the consumer level. These 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. (more…)

Summary

Company Announcement Date:
FDA Publish Date:
Product Type:
Drugs
Reason for Announcement:
Undeclared Methanol subpotency ethyl alcohol
Company Name:
Resource Recovery & Trading, LLC
Brand Name:
Resource Recover & Trading, LLC
Product Description:
Hand Sanitizer

Company Announcement

RESOURCE RECOVERY & TRADING LLC, is voluntarily recalling all the lots manufactured by MXL Comercial S.A. de C.V. of Hand Sanitizer with the next information: HAND SANITIZER 70% Ethyl Alcohol Disinfectant Gel, packaged in 6.7 FL Oz. (200 ml) bottles, UPC 650240026020 and HAND SANITIZER Non-sterile Solution 70% Topical Solution, packaged in 20L (5.28 Gal) liter plastic containers, UPC 37710600013 to the consumer level. The products are being recalled due to the potential presence of undeclared methanol (wood alcohol) and subpotency ethyl alcohol.

Risk Statement: The main concern with the use of hand sanitizer that is sub-potent for ethyl alcohol is the potential for decreased bactericidal and virucidal activity. Adverse health consequences can be related to increased infections. In addition substantial, undeclared methanol exposure, which has inferior antiseptic properties compared to ethanol, 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, young children who accidently 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, RESOURCE RECOVERY & TRADING LLC has not received any reports of adverse events related to this recall. (more…)

Summary

Company Announcement Date:
FDA Publish Date:
Product Type:
Drugs
Reason for Announcement:
Undeclared methanol
Company Name:
Real Clean Distribuciones SA de CV
Brand Name:
Born Basic, Scent Theory and more
Product Description:
Hand Sanitizer

Company Announcement

La Loma, Tlalnepantla, Mexico, Real Clean Distribuciones SA de CV is voluntarily recalling all lots it manufactured within expiry of the following brand names of hand sanitizers:

  • Born Basic ANTI-BAC HAND SANITIZER,
  • Scent Theory KEEP CLEAN Moisturizing Hand Sanitizer,
  • Scent Theory KEEP IT CLEAN Moisturizing Hand Sanitizer, and
  • Lux Eoi Hand Sanitizing Gel 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, Real Clean Distribuciones SA de CV 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. Real Clean Distribuciones SA de CV manufacturers product for four brands included in this recall.

Scent Theory and Born Basic hand sanitizer products are produced by several different manufacturers, in several different countries, and only those lots manufactured by Real Clean in Mexico are subject to the recall.

The recalled products include the following lots:

Manufacturer Product Country of Origin Size Lot Numbers
Real Clean Distribuciones S.A. De C.V. Scent Theory Keep Clean Hand Sanitizer 70% Alcohol Mexico 16.9oz 1633220, 1733220, 1833220, 1933220, 2033220, 2133220, 2233220, 2333220, 2433220, 2533220, 2633220, 2733220, 2833220, 2933220, 3033220, 3133220, 3233220, 3333220, 3433220, 3533220, 3633220, 3733220, 3833220, 3933220, 4033220, 4133220
Real Clean Distribuciones S.A. De C.V. Keep it Clean Hand Sanitizer 70% Alcohol Mexico 16.9oz 0133220, 0233220, 0333220, 0433220, 0533220, 0633220, 0733220, 0833220, 0933220, 1033220 1133220, 1233220, 1333220, 1433220, 1533220
Real Clean Distribuciones S.A. De C.V. Born Basic Anti-Bac Hand Sanitizer 70% Alcohol Mexico 16.9oz 0833420, 0933420, 1033420, 1133420, 1233420, 1333420, 1433420, 1533420, 1633420, 1733420, 1833420, 1933420, 2033420, 2133420, 2233420, 2333420, 2433420, 2533420, 2633420, 2733420, 2833420, 2933420
Real Clean Distribuciones S.A. De C.V. Born Basic Anti-Bac Hand Sanitizer 70% Alcohol Mexico 34oz 0133420, 0233420, 0333420, 0433420, 0533420, 0633420
Real Clean Distribuciones S.A. De C.V. Born Basic Anti-Bac Hand Sanitizer 70% Alcohol Mexico 9.5oz 0133720, 0233720
Real Clean Distribuciones S.A. De C.V. Lux Eoi Hand Sanitizing Gel Mexico 16.9oz 0133920, 0233920, 0333920

Real Clean Distribuciones SA de CV is notifying its distributors by recall letter and consumers via this press release. Real Clean Distribuciones SA de CV is arranging for the return and refund of all recalled products. (more…)

Summary

Company Announcement Date:
FDA Publish Date:
Product Type:
Drugs
Reason for Announcement:
Potential presence of methanol (wood alcohol)
Company Name:
Maquiladora Miniara, S.A. de C.V.
Brand Name:
Shine & Clean
Product Description:
Hand Sanitizer Gel

Company Announcement

Maquiladora Miniara S.A. de C.V. is voluntarily recalling lots of Shine and Clean Hand Sanitizer gel to the consumer level. The products are being recalled due to the potential presence of methanol (wood alcohol)

Risk Statement: 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, young children who accidently ingest these products and adolescents and adults who drink these products as an alcohol (ethanol) substitute, are most at risk for methanol poisoning Maquiladora Miniara S.A. de C.V. has not received any reports of adverse events related to this recall.

These products are used as topical hand sanitizers. The affected Shine and Clean Hand Sanitizer Gel is packaged in 1000 ml bottles and 1-gallon containers. Lot numbers:

F200829088/F200829095/F200829107/D202728743/D202528742/D202428733/D202728743/
D2028753/D202528742/D202428733/ D202028689/ D201828660/ D202428734/E200128784/E200418795/
D202428734/D202828689/D201828660/E201628912/E201628913/E201628911/E201528902/E201528903/
E201628910/E201628918/E201628914/E201628915/E201628916/E201628917/ E202328969/E202428975/
E202528981 /E202128947/ E201728918/E201728919/E201428876/ E201828894/ E201828920/
E201428876/E201128850/E201328859/E200628817/E200828826/E200928840/D202128699/D202428700.

Shine and Clean Hand Sanitizer gel were distributed Nationwide to retail stores via distributors. (more…)

Summary

Company Announcement Date:
FDA Publish Date:
Product Type:
Drugs
Reason for Announcement:
Cross contamination with lidocaine
Company Name:
Fresenius Kabi USA
Brand Name:
Fresenius Kabi
Product Description:
Dexmedetomidine Hydrochloride Injection, 200 mcg/50 mL

Company Announcement

Fresenius Kabi USA is voluntarily recalling two lots of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection, 200 mcg/50 mL (4 mcg / mL), 50 mL fill in a 50 mL vial. Fresenius Kabi initiated this recall due to the possibility of a trace amount of lidocaine present in these two lots and our investigation indicates that this issue is limited to these two product lots. This recall is being performed to the user level.

To date, no adverse drug experience reports have been received for either of the lots being recalled by Fresenius Kabi. Administration of Dexmedetomidine HCl containing trace amounts of lidocaine to a patient with lidocaine allergy, however, could result in anaphylaxis, a potentially life-threatening condition. (more…)

Summary

Company Announcement Date:
FDA Publish Date:
Product Type:
Drugs
Reason for Announcement:
Potential Methanol Contamination
Company Name:
LIQ-E S.A. de C.V.
Brand Name:
Optimus
Product Description:
Hand Sanitizer

Company Announcement

SAN NICOLAS DE LOS GARZA, Mexico — LIQ-E S.A. de C.V. is voluntarily recalling all lots and all bottle sizes of The OPTIMUS Instant Hand Sanitizer due to the potential presence of methanol (wood alcohol) that were shipped into the United States. The products were manufactured between April 27, 2020 and May 08, 2020.

Risk Statement: Substantial methanol exposure could result in nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma, and 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, LIQ-E S.A. de C.V. has not received any reports of adverse events related to this recall. (more…)

Summary

Company Announcement Date:
FDA Publish Date:
Product Type:
Animal & Veterinary
Drugs
Reason for Announcement:
Excess lead in product
Company Name:
InHE Manufacturing, LLC
Brand Name:
Multiple brand names
Product Description:
Hemp Oil Tinctures

Company Announcement

This recall press release was issued by the firm on 06-23-2020 and is subsequently being posted by FDA at this time only to benefit the public for informational purposes.

Human Consumption (MHR Brands)

Tasty Drops – Berry Tincture, 1oz/300mg

FG003175

Tasty Drops – Berry Tincture, 1oz/500mg

FG003137 FG003174, FG003197, FG0057

Tasty Drops – Berry Tincture, 1oz/1500mg

FG003141, FG003202, FG003296

Tasty Drops – Natural Tincture, 1oz/500mg

FG003138, FG003248

Tasty Drops – Natural Tincture, 1oz/1500mg

FG003142, FG003247

Tasty Drops – Spearmint Tincture, 1oz/300mg

FG003167

Tasty Drops – Spearmint Tincture, 1oz/500mg

FG003139, FG003166, FG003191, FG003225, FG003253, FG003263

Tasty Drops – Spearmint Tincture, 1oz/1000mg

FG003095

Tasty Drops – Spearmint Tincture, 1oz/1500mg

FG003143, FG003180, FG003201, FG003224, FG003262

Tasty Drops – Vanilla Tincture, 1oz/300mg

FG003126

Tasty Drops – Vanilla Tincture, 1oz/500mg

FG003140, FG003182, FG003246

Tasty Drops – Vanilla Tincture, 1oz/1500mg

FG003144, FG003249

Made by Hemp – French Vanilla Tincture, 1oz/1000mg

FG003107

Made by Hemp – Mojito Lime Tincture, 1oz/1000mg

FG003110

Made by Hemp – Strawberry Crème Tincture, 1oz/1000mg

FG003109

Pet Consumption (MHR Brands)

Tasty Drops – Cat Tincture 1oz/200mg

FG003156, FG003325

Tasty Drops – Dog Tincture 1oz/200mg

FG003157, FG003286, FG003324

Purfurred – Dog Tincture, 1oz/200mg

FG003188

Made by Hemp – Cat Tincture, 1oz/200mg

FG003178

Made by Hemp – Dog Tincture, 1oz/200mg

FG003179

Human Consumption (White Label)

A Clean Choice – French Vanilla Tincture, 1oz/1000mg

FG003106

A Clean Choice – Strawberry Creme Tincture, 1oz/1000mg

FG003108

A Clean Choice – Spearmint Tincture, 1oz/500mg

FG003113

BC Hemp Co LLC – Berry Tincture, 1oz/500mg

FG003312

BC Hemp Co LLC – Natural Tincture, 1oz/500mg

FG003171, FG003183, FG003316

BC Hemp Co LLC – Spearmint Tincture, 1oz/500mg

FG003315

BC Hemp Co LLC – Berry Tincture, 1oz/1000mg

FG003164

BC Hemp Co LLC – Natural Tincture, 1oz/1000mg

FG003318

Goodness Gurus – Berry Tincture, 1oz/500mg

FG003236

Goodness Gurus – Spearmint Tincture, 1oz/500mg

FG003234

Goodness Gurus – Spearmint Tincture, 1oz/1000mg

FG003238

Goodness Gurus – Spearmint Tincture, 1oz/1500mg

FG003237

Herbzeedy LLC – Natural Tincture, 1oz/500mg

FG003122, FG003123

Herbzeedy LLC – Natural Tincture, 1oz/1500mg

FG003121

Javan Anti Aging – Spearmint Tincture, 1oz/300mg

FG003283

Pathway to Wellness – Natural Tincture, 1000mg/30ml

FG003151

The Spiffy Piff – Berry Tincture, 1oz/300mg

FG003277

The Spiffy Piff – Spearmint Tincture, 1oz/300mg

FG003276

Recovery ReLeaf – Vanilla Tincture, 1oz/1000mg

FG003133

Acadia Farms – Canadian Maple Tincture, 1oz/300mg

FG003181

Acadia Farms – Spearmint Tincture, 1oz/300mg

FG003177

Pet Consumption (White Label)

Herbal Renewals – Cat Tincture, 1oz/200mg

FG003213

Herbal Renewals – Pet Blend, 1oz/200mg

FG003223, FG003310

Barkley Bistro – Dog Tincture, 1oz/200mg

FG003145

A Clean Choice – Cat Tincture, 1oz/200mg

FG003117

A Clean Choice – Cat Tincture, 500mg/1oz.

FG003118

A Clean Choice – Dog Tincture, 1oz/200mg

FG003116

A Clean Choice – Dog Tincture, 500mg/1oz.

FG003115

BC Hemp Co LLC – Pet Tincture, 1oz/200mg

FG003165

Boost IV Hydration, LLC – Dog Tincture, 1oz/200mg

FG003270

Acadia Farms – Pet Blend, 1oz/200mg

FG003176

How the company learned of this situation: The Company was recently advised by the Florida Department of Health of the presence of elevated heavy metals (lead) in some of its products. In response to this information, the Company undertook an investigation and determined that the issue related to graduated droppers provided by a third-party packaging supplier.

Exposure to lead could present physical signs and symptoms including, pain, paresthesia/muscle weakness, abdominal pain, nausea, vomiting, diarrhea, constipation, poor appetite, weight loss, symptoms associated with encephalitis, metallic taste in the mouth, shock, hemolysis or kidney damage.

In response and in conjunction with the regulatory authorities, the Company:

  1. issued a voluntary nationwide recall of the affected products, providing every customer with replacement products at no cost to the customer; and
  2. retained a replacement third-party packaging supplier for all replacement and future products.
  3. Discontinue use of graduated droppers in the future.

Prior to notifying customers of this recall, MHR Brands had not received any reports of adverse health effects regarding the recalled products. Consumers should contact their physician or healthcare provider if they experience any symptoms that may be related to using the products being recalled. Consumers should observe pets and contact their veterinarian as signs and symptoms of lead exposure in pets may be similar to those in humans. (more…)

Summary

Company Announcement Date:
FDA Publish Date:
Product Type:
Drugs
Reason for Announcement:
Potential Undeclared Methanol Contamination
Company Name:
AAA Cosmetica, S.A. de C.V.
Brand Name:
bio aaa
Product Description:
Hand Sanitizer

Company Announcement

AAA Cosmética, S.A. de C.V. is voluntarily recalling all lots of bio aaa Advance Hand Sanitizer currently in US distribution, packaged in 480 mL bottles, 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, diarrhea, vomiting, severe abdominal pain, headache, blurred vision, permanent blindness, seizures, coma, permanent damage to the nervous system, or death. Persons using these products on their hands may be at risk; however young children who accidently ingest them and adolescents and adults who drink these products are most at risk for methanol poisoning. To date, AAA Cosmética has not received any complaints or adverse event reports related to this recall. (more…)

Summary

Company Announcement Date:
FDA Publish Date:
Product Type:
Drugs
Reason for Announcement:
Potential Methanol Contamination
Company Name:
Soluciones Cosmeticas
Brand Name:
Bersih
Product Description:
Hand Sanitizer Gel

Company Announcement

Soluciones Cosméticas is voluntarily recalling all lots of Bersih Hand Sanitizer Gel Fragrance Free sold in 16.9 ounce bottles to the consumer level. The products are being recalled due to the potential presence of methanol (wood alcohol).

Risk Statement: 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, young children who accidently 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 Soluciones Cosméticas has not received reports of adverse events related to this recall. (more…)

Summary

Company Announcement Date:
FDA Publish Date:
Product Type:
Drugs
Reason for Announcement:
Undeclared Methanol
Company Name:
4e Brands North America
Brand Name:
Blumen
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. (more…)