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Hand Sanitizer

Updated: June 22, 2021 3:01 PM
Company name: Sanit Technologies LLC d/b/a Durisan
Brand name: Durisan
Product recalled: Hand sanitizer and hand sanitizing wipes
Reason of the recall: Microbial contamination
FDA Recall date: June 22, 2021
Recall details: Sanit Technologies LLC d/b/a Durisan, is providing an additional 5 label illustrations and product sizes... See More for customers that might not have been able to clearly identify containers of Non-Alcohol Hand Sanitizer products that were added to the voluntary recall initiated on March 24, 2021, and expanded by the April 10 and May 14, 2021 notices. To avoid any confusion, this press release provides copies of label illustrations for the recalled products.

Durisan Non Alcohol Antimicrobial Hand Sanitizer products became contaminated with a common municipal water supply borne bacteria, Burkholderia contaminans. Use of a hand sanitizer contaminated with Burkholderia contaminans, generally considered to be of low virulence, can range from no reaction to possible infections in a person with a hand wound or scrapes because the bacteria could enter the bloodstream, especially in patients with compromised immune systems.

To date, no qualified reports of adverse reactions have been reported related to this recall.

The product is intended to be applied topically to help reduce bacteria on the skin that could cause diseases when soap and water are not available. The list of the lot numbers of the recalled products, which have a 24-month expiration, is included below.

Consumers and customers in possession of Durisan Non Alcohol Antimicrobial Hand Sanitizer products with these numbers in any form factor are encouraged to contact Durisan to return it.

The product is packaged in sizes ranging from 18mL credit card to 1-gallon containers. The lot number can be found in black print on the bottom of the package. Durisan Antimicrobial Solutions Hand Sanitizer Sizes With the Following Identification

- Volume mL: 18. Volume oz: 0.61. UPC: 8 52379 00614 1. NDC: 71120-112-01.
- Volume mL: 50. Volume oz: 1.69. UPC: 8 52379 00634 9. NDC: 71120-611-20.
- Volume mL: 118. Volume oz: 4. UPC: 8 52379 00612 9. NDC: 71120-112-10.
- Volume mL: 236. Volume oz: 8. UPC: 8 52379 00635 6. NDC: 71120-112-11.
- Volume mL: 250. Volume oz: 8.45. UPC: 8 52379 00611 0. NDC: 71120-611-03.
- Volume mL: 300. Volume oz: 10. UPC: 8 52379 00697 4. NDC: 71120-112-08.
- Volume mL: 550. Volume oz: 18.59. UPC: 8 52379 00620 2. NDC: 71120-112-06.
- Volume mL: 1000. Volume oz: 33.81. UPC: 8 52379 00610 3. NDC: 71120-112-05.
- Volume mL: 3785. Volume oz: 128. UPC: 8 52379 00621 9. NDC: 71120-611-05.
- Volume mL: 160 Ct Wipe. Volume oz: 5.63. UPC: 8 52379 00631 8. NDC: 71120-111-01.
- Volume mL: 80 Ct Wipe. Volume oz: 2.81. UPC: 8 52379 00632 5. NDC: 71120-111-03.
- Volume mL: 240 Ct Wipe. Volume oz: 8.44. UPC: 8 52379 00633 2. NDC: 71120-111-03.

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

Check the full recall details on fda.gov

Source: FDA
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Company name: Prairie Wolf Spirits, Inc.
Brand name: Prairie Wolf Distillery
Product recalled: Hand sanitizer packaged in 16.9 fluid ounce and 20 fluid ounce containers that resemble water bottles
Reason of the recall: Packaged in containers resembling water bottles
FDA Recall date: June 22, 2021
Recall details:... See More Oklahoma City, Oklahoma, Prairie Wolf Spirits, Inc. is voluntarily recalling all lots of Prairie Wolf Distillery hand sanitizer packaged in 16.9 fluid ounce and 20 fluid ounce containers that resemble water bottles to the consumer level. The recall does not affect any other hand sanitizer products from Prairie Wolf Distillery. The product poses a risk of ingestion.

Ingesting hand sanitizer, which is intended for topical use, could potentially result in alcohol toxicity. Symptoms of alcohol toxicity may range from lack of coordination, slowed or slurred speech, drowsiness to coma, which can be fatal.

Furthermore, ingesting alcohol can affect the brain and cause impaired driving or operating heavy machinery. Alcohol can also interact with numerous drugs which may result in serious adverse effects. Ingesting alcohol by people with alcohol addiction may interfere with maintaining abstinence. Additionally, people with alcohol addiction may seek large amounts of ethanol-based hand sanitizers as a substitute.

To date, Prairie Wolf Spirits has received no reports of adverse reactions related to this recall. The product is intended to be applied topically to help reduce bacteria on the skin that could cause diseases when soap and water are not available and is packaged in 16.9 ounce (UPC 6000331899) and 20 ounce plastic bottles (UPC 6000365984) that resemble water bottles. The product can be identified by the bottle’s labels pictured. The product was distributed to selected customers and consumers nationwide in the United States.

Prairie Wolf Spirits is notifying its customers by mail and is arranging for return or replacement of all recalled products. The product was sold from a temporary retail location located at 111 E. Oklahoma Avenue, Guthrie, Oklahoma 73044. Additionally, it was available on the manufacturer’s website, but there were limited sales. Prairie Wolf Spirits also donated the products from its Guthrie warehouse. Consumers that have the product which is being recalled should stop using it and return it to the Prairie Wolf Spirits distillery, 124 E. Oklahoma Avenue, Guthrie, Oklahoma, or discard it.

Consumers should contact their physician or healthcare provider if they have 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.

Check the full recall details on fda.gov

Source: FDA
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Company name: Dibar Nutricional S. de R.L. de C.V.
Brand name: DIBAR Labs, ProtectoRx
Product recalled: Hand Sanitizer
Reason of the recall: Presence of methanol
FDA Recall date: May 19, 2021
Recall details: Morelia, Michoacán, Mexico, Dibar Nutricional S. de R.L. De C.V. (“Dibar”) is voluntarily recalling... See More all Dibar Labs Hand Sanitizer packaged in 8oz and 16 oz bottles, respectively, to the consumer level (see Label 1 below). Dibar is also voluntarily recalling ProtectoRx Hand Sanitizer packaged in 2oz and 16oz fluid ounce bottles, respectively, to the consumer level (see Label 2 below), as well as all Advance Hand Sanitizer packaged in 16 oz bottles, likewise, to the consumer level (see Label 3 below). These products are being recalled after testing conducted by our firm revealed the presence of methanol.

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 accidentally ingest the products and adolescents and adults who drink the products as an alcohol (ethanol) substitute are most at risk for methanol poisoning.

To date, the company has not received any reports of adverse reactions related to this recall. 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 bottles of hand sanitizer include a twelvedigit lot code printed on the bottle near the base. The products can be identified by the label image provided at the end of this release. Products labeled as Dibar Labs Hand Sanitizer were distributed nationwide in the USA through S.E.N.D. LLC and its customers. Products labeled as ProtectoRx Hand Sanitizer were distributed in Puerto Rico through PR TRADING LLC and its customers. Products labeled as Advance Hand Sanitizer were distributed in the USA through RGV HEALTH SERVICES LLC DBA VALLEY and its customers.

Dibar Nutricional S. de R.L. De C.V., has notified its direct distributors by letter and asked that they remove the recalled products from commerce immediately if they still possess inventory.

Consumers, distributors and retailers that have the hand sanitizers which are being recalled should stop using, distributing and/or selling them and return them to the place of purchase. Consumers should contact their physician or healthcare provider if they have 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.

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

Check the full recall details on fda.gov

Source: FDA
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Company name: Essaar Inc.
Brand name: Soho Fresh
Product recalled: 70% Rubbing Alcohol
Reason of the recall: Contaminated with Methanol
FDA Recall date: January 04, 2021
Recall details: Company Announcement Essaar Inc. is voluntarily recalling lot 200528303 of Soho Fresh 70% Rubbing Alcohol in 33.81 oz. clear... See More plastic bottles to the consumer level. FDA analysis of the product revealed it is contaminated with methanol. 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, Essar Inc. has not received any reports of adverse events related to this recall. The product is used as an external purpose use rubbing alcohol and is packaged in 33.81 oz. clear plastic bottles with lot number 200528303 and UPC 7502268987367.

Soho Fresh was distributed nationwide to retail stores. Essaar Inc. is notifying its distributors and customers by email and mail and is arranging for the return of all recalled product to Essaar Inc. Consumers that have product which is being recalled should stop using and discard or return to place of purchase or to Essaar Inc. contacting via email or phone or mailing address mentioned above for arrangements of return. Consumers who have purchased this product should not open the package or use the contents. Instead, they should return the product to the location of purchase for a full refund or call Essaar Inc. at 201-647-7606 Monday to Friday 9am to 5pm, Eastern Standard Time. Essaar Inc. can also be reached via email at essaarinc@yahoo.com.

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug 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. FDA’s update  

Check the full recall details on fda.gov

Source: FDA
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Company name: Ashtel Studios
Brand name: Smart Care
Product recalled: Hand sanitizer packaged in 0.84 oz. pouches
Reason of the recall: Product is packaged in containers resembling a food and drink pouch
FDA Recall date: October 02, 2020
Recall details: Company Announcement Ashtel Studios has announced a... See More voluntary recall of all lots of licensed hand sanitizer packaged in .84 oz containers resembling food and drink pouches labeled with various children’s characters listed in the table below to the consumer level.

The products are being recalled because they are packaged in containers resembling food and drink pouch. The recall does not affect any other Hand Sanitizer products from Ashtel Studios.

Product Size NDC
PAW Patrol Hand Sanitizer 0.84 FL. OZ (25 mL) 70108-042-01
JoJo Siwa Hand Sanitizer 0.84 FL. OZ (25 mL) 70108-044-01
Hot Wheels Hand Sanitizer 0.84 FL. OZ (25 mL) 70108-045-01
Barbie Hand Sanitizer 0.84 FL. OZ (25 mL) 70108-046-01
Trolls Hand Sanitizer 0.84 FL. OZ (25 mL) 70108-047-01
Minions Hand Sanitizer 0.84 FL. OZ (25 mL) 70108-043-01

Ingesting hand sanitizer, which is intended for topical use, could potentially result in alcohol toxicity. Symptoms of alcohol toxicity may range from lack of coordination, slowed or slurred speech, drowsiness to coma, which can be fatal. Furthermore, ingesting alcohol can affect the brain and cause impaired driving or operating heavy machinery. Alcohol can also interact with numerous drugs which may result in serious adverse effects. Ingesting alcohol by people with alcohol addiction may interfere with maintaining abstinence. Additionally, people with alcohol addiction may seek large amounts of ethanol-based hand sanitizers as a substitute. Ashtel Studios has received no reports of adverse reactions.

The product is intended to be applied topically to help reduce bacteria on the skin that could cause diseases when soap and water are not available and is packaged in 0.84 oz pouches. The product can be identified by examples of the products pictured below. Product was distributed to selected retailers in the United States and Canada.

Ashtel Studios has provided written notification to its distributors and retailers and is alerting customers via this voluntary recall. While the product is not available for purchase, if a consumer has product which is being recalled they are advised to destroy it immediately.

Check the full recall details on fda.gov
Source: FDA
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Company name: Estado de México, México, DMM VISSION, S.A. de C.V
Brand name: Cleaner
Product recalled: Cleaner Hand Sanitizer
Reason of the recall: Potential Presence of Methanol (Wood Alcohol)
FDA Recall date: September 30, 2020
Recall details: Company Announcement Estado de México, México, DMM VISSION, S.A. de... See More C.V. is voluntarily recalling five lots of Cleaner Hand Sanitizer, 500 mL and 1,200 mL plastic clear bottles with white tops currently in US distribution to the consumer level. This recall is being initiated out of abundance of caution due to detection of methanol (wood alcohol) in hand sanitizer sample manufactured at the same facility. 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 DMM VISSION has not received reports of adverse events related to this recall. The product is used as a hand sanitizer and are packaged in 500ml and 1200ml plastic clear bottles with white tops. The lot numbers are LC2020407, LC2020408, LC2020502, LC2020504, LC2020507.  This product was first distributed nationwide to wholesale distributors on April 27, 2020 and finished on June 9th, 2020. The recalled products are as follows:
Check the full recall details on fda.gov
Source: FDA
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Company name: Medek, LLC
Brand name: M
Product recalled: M Hand Sanitizer Alcohol Antiseptic 80%
Reason of the recall: Contains Methanol and may be Sub-Potent for Ethanol
FDA Recall date: September 10, 2020
Recall details: Medek, LLC is voluntarily recalling all lots of M Hand Sanitizer Alcohol... See More Antiseptic 80% 128 oz/3,785 mL to the consumer level. FDA analysis found the M Hand Sanitizer to contain methanol and be sub-potent for ethanol.

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. In addition, the use of sub-potent hand sanitizer products can have adverse health consequences related to lack of efficacy and increased risk of infections. To date, Medek, LLC. has not received any reports of adverse.

The recalled product is used as a hand sanitizer for hand washing to decrease bacteria on the skin when soap and water are not available. The recalled Hand Sanitizer is packaged in a one (1) gallon (128 oz/3,785 mL) High-density polyethylene (HDPE) plastic bottle, NDC 75432-001-02. The recalled Hand Sanitizer was distributed directly to walk-in customers in Alamo, TX, between the dates of 04/17/2020 to 05/22/2020.

Medek, LLC is notifying its customers/distributors by recall letter and consumers via this press release. We are also notifying our distributors, who will help notify their customers by phone calls, emails, and/or mailed letters and is arranging for return of all recalled Hand Sanitizer. Consumers, distributors, and retailers that have recalled products should stop use or distribution and return to place of purchase. Consumers with questions regarding this recall can contact Medek, LLC at (956) 800-4366 (Monday to Friday from 9 am to 5 pm CST).

Consumers should contact their physician or healthcare provider if they experience any problem that may be related to the use of 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.

Check the full recall details on fda.gov

Source: FDA
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Company name: CorgioMed LLC
Brand name: Leafree
Product recalled: Hand sanitizer
Reason of the recall: Product is labeled as edible alcohol.
FDA Recall date: September 03, 2020
Recall details: CorgioMed, LLC is voluntarily recalling all lots of Leafree Instant Hand Sanitizer-Aloe Vera, within expiry to the consumer... See More level.  The products are being recalled because they are labeled as “EDIBLE ALCOHOL”. Leafree Hand Sanitizer is an alcohol-based hand rub to be applied externally to reduce bacteria on the skin when soap and water are not available.

Risk Statement: Ingesting hand sanitizer, which is intended for topical use, may result in alcohol toxicity. Symptoms of alcohol toxicity may range from lack of coordination, slowed or slurred speech, drowsiness to coma, which can be fatal. Young children may experience a sharp decrease in blood sugar which may result in death. Pregnant women who ingest alcohol have experienced birth defects and developmental disabilities. Nursing mothers who ingest alcohol in above moderate levels may see developmental, growth and sleep pattern damages in their babies and may experience impaired judgement and ability to safely care for their child.

Furthermore, ingesting alcohol can affect the brain and cause impaired driving or operating heavy machinery. Alcohol can also interact with numerous drugs which may result in serious adverse effects. Ingesting alcohol by people with alcohol addiction may interfere with maintaining abstinence. Additionally, people with alcohol addiction may seek large amounts of ethanol-based hand sanitizers as a substitute.  The labeling of this product as ‘edible alcohol’ may promote this behavior. The product is used as a hand sanitizer and is packaged in 100 ml (UPC #6970495860325), 300 ml (UPC #69705860318) and 500 ml (UPC #6970495860301) bottles. 

Product was distributed Nationwide via CorgioMed website. CorgioMed LLC is notifying its distributors and customers by email and is arranging for return or disposal of all recalled products. Distributors and Consumers with questions regarding this recall can contact CorgioMed LLC by emailing to: contact@corgiomed.comor phone: 301-978-3898 from September 1st to September 30th, 2020. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug 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.
Check the full recall details on fda.gov

Source: FDA
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Company name: AJR Trading LLC
Brand name: bio aaa
Product recalled: Hand Sanitizer
Reason of the recall: Possible presence of methanol
FDA Recall date: September 03, 2020
Recall details: AJR Trading is voluntarily recalling 2,004 units of lot 20DF8307 of bio aaa Advance Hand Sanitizer currently in... See More US distribution, packaged in 480 mL bottles, to the consumer level. This lot of bio aaa Advance Hand Sanitizer has been tested and meets all appropriate specifications and tests. However, in an abundance of caution, these units are being recalled because of possible presence of methanol in other lots of bio aaa Advance Hand Sanitizer.

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 may be at risk; young children who accidently ingest them and adolescents and adults who drink these products as an alcohol (ethanol) substitute, are most at risk for methanol poisoning.

To date, AJR Trading has not received reports of adverse events related to this recall.

The product is used as a hand sanitizer to reduce bacteria when soap and water is not available and is packaged in 480 mL plastic bottles UPC 7502272121085.  AJR Trading is recalling lot 20DF8307, expiration date April 2022. The product can be identified by the images below. Product was distributed in Miami beginning in April 2020. AJR Trading is notifying its customers by phone calls, e-mails, and letters.  AJR Trading is arranging for refund and destruction of recalled products.

Consumers/distributors/retailers that have the above listed lots of bio aaa Hand Sanitizer, which is being recalled, should stop using or distributing the products immediately and mail the products to AJR Trading at the following address for refund: 814 Ponce de Leon Blvd, suite 218. Coral Gables, FL. 33134. Consumers with questions regarding this recall can contact AJR Trading by phone insert 305-302-8416 or e-mail to ajrtrading15@gmaill.com Monday to Friday from 10:00 am to 5:00 pm Central Time.

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

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

Check the full recall details on fda.gov

Source: FDA
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Company name: HARMONIC NATURE S. DE R.L. Mi
Brand name: Harmonic Nature
Product recalled: Hand sanitizer
Reason of the recall: Product contains 1 propanol
FDA Recall date: August 28, 2020
Recall details: Guadalupe, Nuevo Leon, Harmonic Nature is voluntarily recalling all 800 bottles Hand Sanitizer, 250mL, product... See More due to the potential presence of 1-propanol. The products have been tested and found to contain 1 propanol.

Risk Statement: Any amount of 1-propanol with a concentration greater than or equal to 1% by volume that is unlisted in a product labeled as an ethanol-based hand sanitizer has a reasonable probability of acute toxicity from ingestion which can cause central nervous system depression, which could result in death, permanent impairment, or necessitate medical or surgical intervention. Populations most at risk include individual with alcohol addiction and adolescents, who have been known to ingest ethanol-based antiseptic rubs intentionally to become intoxicated, as well as infants and children who may unintentionally ingest the defective product.

Harmonic Nature has not received any reports of adverse events related to this recall. The product is used as a hand sanitizer and is packaged in 250 mL plastic bottles , with UPC Code 7500462892210. The product can be identified by Harmonic Nature as a hand sanitizer Topical Solution distributed only to and currently on hold at the US custom bróker, Aquiles INC. Harmonic Nature is notifying Aquiles INC. and is arranging for return of all recalled product. Consumers with questions regarding this recall can contact Harmonic Nature by +(52) 8120 2967 03 or miguel_martinez2000@yahoo.com Monday to Friday from 8:00 am to 6:00pm central time. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug 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.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration. CDER’s press statement

Check the full recall details on fda.gov

Source: FDA
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