nanoMaterials Discovery Corporation Issues Voluntary Nationwide Recall of its Alcohol Antiseptic 80% Alcohol Solution

Feb 14, 2023 | Audience: Consumers

February 14, 2023 – Seattle, Washington, nanoMaterials Discovery Corporation is voluntarily recalling all lots of its Alcohol Antiseptic 80% Alcohol Solution branded as “Snowy Range Blue” in four fluid ounce spray dispenser packaging to the consumer level. Certain batches of the company’s Alcohol Antiseptic 80% Alcohol Solution may exceed FDA limits for methanol.

Risk Statement: The affected Alcohol Antiseptic 80% Alcohol Solution with methanol concentrations that exceed FDA limits potentially could result in nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma, permanent damage to the nervous system or death. Young children who accidentally ingest these products and adolescents and adults who drink these products as an alcohol (ethanol) substitute are most at risk. nanoMaterials Discovery Corporation has not received any reports of adverse events related to this recall.

The product is used as a hand sanitizer to help reduce bacteria that potentially can cause disease. The product is for use when soap and water are not available. The affected Alcohol Antiseptic 80% Alcohol Solution is packaged in four fluid ounce spray dispenser bottles bearing the code NDC 75288-100-04. The product can be identified by the four fluid ounce spray dispenser bottle packaging and the product labeling pictured below. The affected Alcohol Antiseptic 80% Alcohol Solution was sold nationwide to distributors. Sales of this product were discontinued in Q4 2021.

nanoMaterials Discovery Corporation is notifying its distributors by mail and is arranging for return or disposal of all recalled products. Consumers/distributors/retailers that have Alcohol Antiseptic 80% Alcohol Solution branded as “Snowy Range Blue”, which is being recalled, should stop using and return to place of purchase or discard.

Consumers with questions regarding this recall can contact nanoMaterials Discovery Corporation at anesepticrecall@gmail.com. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to 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.

Source: FDA

PNHC, LLC d/b/a Heal the World Issues Voluntary Nationwide Recall of Heal the World Hand Sanitizer Packaged in 9.6 Ounce Bottles Because They Resemble Small Water Bottles

Mar 17, 2021 | Audience: Consumers

March 17, 2021 -- Raleigh, North Carolina, PNHC, LLC, d/b/a Heal the World, is voluntarily recalling all lots of Heal the World hand sanitizer packaged in 9.6 fl. oz containers to the consumer level. The products are being recalled because they resemble 9.6ounce water bottles. The recall does not affect any other Hand Sanitizer products from PNHC, LLC and/or Heal the World.

Product	Size	NDC
Heal the World Hand Sanitizer	9.6 FL. OZ (285 mL)	73333-285-01

Lot Nos. SAA21, SAA24, SAA27, SAA22, SAA23, SAA29, SAA26, SAA28, SAA25, SAA32, SAA55, SAA56, SAA44, SAA60.

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, PNHC, LLC, d/b/a Heal the World has received no reports of adverse reactions and no complaints have been received.

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 9.6 ounce plastic bottles. The product can be identified by the bottle’s label pictured below. Product was distributed to selected retailers in the United States.

PNHC, LLC has provided notification to its distributors and retailers. Distributors and retailers that have product which is being recalled should stop distribution. While the product is not available for purchase and has not been available for several months, if a consumer has product which is being recalled he or she is advised to contact the entity who sold the product to consumer for return.

Consumers with questions regarding this recall can contact PNHC, LLC at 813-434-0741 from 9:00 am- 5:00 pm EST, Monday through Friday. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to 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.

Source: FDA

Essaar Inc. Issues Voluntary Nationwide Recall of Rubbing Alcohol Contaminated with Methanol

Jan 4, 2021 | Audience: Consumer

January 4, 2021 -- Essaar Inc. is voluntarily recalling lot 200528303 of Soho Fresh 70% Rubbing Alcohol in 33.81 oz. clear 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. 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.

Source: FDA

FDA Warns Consumers of Risk of Methanol Contamination in Certain Hand Sanitizers

Jul 7, 2020 | Audience: Consumers

List of Alcohol-Based Hand Sanitizer Products Containing Methanol (FDA)

FDA advises consumers not to use hand sanitizers on this list.

July 7, 2020 (update) -- FDA is warning consumers and health care providers that the agency has seen a sharp increase in hand sanitizer products that are labeled to contain ethanol (also known as ethyl alcohol) but that have tested positive for methanol contamination. Methanol, or wood alcohol, is a substance that can be toxic when absorbed through the skin or ingested and can be life-threatening when ingested.

The agency is aware of adults and children ingesting hand sanitizer products contaminated with methanol that has led to recent adverse events including blindness, hospitalizations and death.

Methanol is not an acceptable active ingredient for hand sanitizers and must not be used due to its toxic effects. FDA’s investigation of methanol in certain hand sanitizers is ongoing. The agency will provide additional information as it becomes available.

Consumers who have been exposed to hand sanitizer containing methanol and are experiencing symptoms should seek immediate treatment for potential reversal of toxic effects of methanol poisoning. 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 for methanol poisoning, young children who accidently ingest these products and adolescents and adults who drink these products as an alcohol (ethanol) substitute, are most at risk.

FDA reminds consumers to wash their hands often with soap and water for at least 20 seconds, especially after going to the bathroom; before eating; and after coughing, sneezing, or blowing one’s nose. If soap and water are not readily available, the Centers for Disease Control and Prevention (CDC) recommend consumers use an alcohol-based hand sanitizer that contains at least 60 percent ethanol (also referred to as ethyl alcohol).

FDA remains vigilant and will continue to take action when quality issues arise with hand sanitizers. The agency is especially concerned with:

The dangers of drinking any hand sanitizer under any conditions. While hand sanitizers with possible methanol contamination are more life-threatening than those that are not contaminated, FDA urges consumers not to drink any of these products.
Certain hand sanitizers that may not contain a sufficient amount of ethyl alcohol or isopropyl alcohol.
Hand sanitizers that are sold or offered for sale with false and misleading, unproven claims that they can prevent the spread of viruses such as COVID-19, including claims that they can provide prolonged protection (e.g., for up to 24-hours).
Products that are fraudulently marketed as “FDA-approved” since there are no hand sanitizers approved by FDA.
Products packaged to appear as drinks, candy or liquor bottles, as well as products marketed as drinks or cocktails because their appearance could result in accidental ingestion or encourage ingestion. Children are particularly at risk with these products since ingesting only a small amount of hand sanitizer may be lethal in a young child.

FDA is aware of reports of adverse events associated with hand sanitizer products. FDA encourages health care professionals, consumers and patients to report adverse events or quality problems experienced with the use of hand sanitizers to FDA’s MedWatch Adverse Event Reporting program (please provide the agency with as much information as possible to identify the product):

Complete and submit the report online; or
Download and complete the form, then submit it via fax at 1-800-FDA-0178.

FDA’s testing and manufacturer’s recalls

The chart outlines the information on hand sanitizer labels for consumers to use to identify a product that has been tested by FDA and found to contain methanol, that is being recalled by the manufacturer or distributor, that is purportedly made at the same facility as products in which FDA has tested and confirmed methanol contamination and/or that has been identified through the agency’s registration and listing database. FDA advises consumers not to use hand sanitizers from these companies, or products with these names or NDC numbers.

Source: FDA

Pharmacist Choice Alcohol Prep Pads by Simple Diagnostics: Recall - Lack of Sterility Assurance and Other Quality Issues

Dec 5, 2017 | Audience: Pharmacy, Consumer

[Posted 12/05/2017]

ISSUE: Simple Diagnostics is voluntarily recalling three lots of Pharmacist Choice Alcohol Prep Pads (UPC # 898302001050, NDC # 98302-0001-05), which were manufactured by Foshan Flying Medical Products Co. Ltd., located in China, due to the lack of sterility assurance and other quality issues. The affected lots are:

SD2070421201 (Exp. 12/2019)
SD2070420925 (Exp. 09/2019)
SD2070420601 (Exp. 12/2019)

The affected lots were distributed between 10/18/2016 and 07/19/2017.

The use of impacted Alcohol Prep Pads could result in adverse events such as infections.

BACKGROUND: Pharmacist Choice Alcohol Preps are supplied to distributors and pharmacies. Pharmacist Choice Alcohol Preps are used by health care professionals and patients for preparation of the skin prior to injection, as well as in first aid to decrease germs in minor cuts, scrapes and burns.

RECOMMENDATION: Simple Diagnostics is notifying its distributors and customers by issuing a “Dear Customer” letter and arranging for the return of all recalled products. Healthcare providers that have affected lots of Pharmacist Choice Alcohol Prep Pads that have been recalled should stop using the product and should return them to Simple Diagnostics.

Health professionals and consumers with questions regarding this recall can contact Simple Diagnostics at 1-877-342-2385.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report Online: www.accessdata.fda.gov/scripts/medwatch/index.cfm
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

[11/30/2017 - Press Release - Simple Diagnostics]

Alcohol Pads or Benzalkonium Chloride Antiseptic Towelettes by Foshan Flying Medical Products: FDA Alert - Lack of Sterility Assurance and Other Quality Issues

Sep 1, 2017 | Audience: Pharmacy, Health Professional, Patient

[Posted 09/01/2017]

ISSUE: The U.S. Food and Drug Administration is alerting health care professionals and patients not to use alcohol pads or benzalkonium chloride antiseptic towelettes made by Foshan Flying Medical Products Co. Ltd., located in China, due to the lack of sterility assurance and other quality issues. These products are distributed by Total Resources International, Walnut, California, and Simple Diagnostics Inc., Williston Park, New York. The use of these alcohol pads and antiseptic towelettes could cause infections.

BACKGROUND: FDA initially contacted Foshan on May 25, 2017, regarding a recall, and had several follow-up meetings with the company. However, Foshan has not taken action to remove its alcohol pads or antiseptic towelettes from the market.

FDA placed all drug products made by Foshan on import alert on May 23, 2107, to stop these products from entering the United States. However, FDA is concerned these products might still be in U.S. distribution. FDA also sent Foshan a warning letter on August 1, 2017, for violations of current good manufacturing practice regulations.

RECOMMENDATION: Patients, health care facilities and pharmacies that have alcohol pads and antiseptic towelettes labeled by Total Resource or Simple Diagnostics should immediately stop using them and discard the products. Patients should contact a doctor if they experienced any adverse reactions after using these products.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report Online: www.accessdata.fda.gov/scripts/medwatch/index.cfm
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

[09/01/2017 -Alert - FDA]

Over-the-Counter Topical Antiseptic Products: Drug Safety Communication - FDA Requests Label Changes and Single-Use Packaging to Decrease Risk of Infection

Nov 13, 2013 | Audience: Healthcare Professionals, Risk Managers, Pharmacy

ISSUE: The U.S. Food and Drug Administration (FDA) is requesting label and packaging changes to enhance the safe use of certain over-the-counter (OTC) topical antiseptic products. This request is the result of our ongoing evaluation of infrequent but continuing reports of infections resulting from antiseptic products labeled for preoperative or preinjection skin preparation. When used properly, topical antiseptics are safe and effective products to reduce the number of bacteria on patients’ skin prior to surgery or injections. However, most often, contamination of topical antiseptics occurs when organisms are introduced into the product by users. Therefore, health care professionals and patients should follow all label directions to decrease the chances of infection.
Outbreaks associated with the use of contaminated topical antiseptics have been reported in the medical literature and to the Centers for Disease Control and Prevention (CDC). Clinical infections have also been reported to FDA, leading to some product recalls. The reported outcomes ranged from localized infections at injection sites to systemic infections that resulted in death. FDA has reviewed reports of four deaths, five cases of wound infection, seven cases of peritonitis, 10 cases of septic arthritis, 14 cases of indwelling catheters requiring replacement, 16 cases of injection site infection, and 32 cases of bacteremia. These infections have been confirmed to be caused by contaminated antiseptic products. Affected products included all commonly used antiseptic ingredients, including alcohol, iodophors, chlorhexidine gluconate, and quaternary ammonium products. Organisms implicated in the outbreaks included Bacillus cereus, Burkholderia cepacia, Pseudomonas aeruginosa, Achromobacter xylosoxidans, Ralstonia pickettii, Serratia marcescens, and Mycobacterium abscessus.

BACKGROUND: Over-the-counter (OTC) topical antiseptic drugs for use according to the label instructions to reduce the number of bacteria on the skin prior to surgery or injections. When used properly, over-the-counter (OTC) topical antiseptics are safe and effective products to reduce the number of bacteria on the skin prior to surgery or an injection. Commonly used products contain isopropyl or ethyl alcohol, povidone iodine, poloxamer iodine, benzalkonium chloride, benzethonium chloride, or chlorhexidine gluconate as a single agent or in combination with alcohol. These products are marketed as solutions, swabs, pads saturated with a solution, and applicators containing a solution. Currently available as both single-use and multiple-use products.

Topical antiseptics are not required to be manufactured as sterile and so may become contaminated with bacteria during manufacturing. Labeling stating a product is sterile means it was treated with a process during manufacturing to eliminate all potential microorganisms. However, even topical antiseptics manufactured with a sterile process, can become contaminated if proper care is not taken when using them. The term nonsterile on the product label means it was not sterilized during manufacturing; it does not mean the product contains harmful bacteria.

RECOMMENDATION: To further reduce the risk of infection with improper topical antiseptic use and the possibility of these products becoming contaminated with bacteria during use, we are requesting that manufacturers package antiseptics indicated for preoperative or preinjection skin preparation in single-use containers.

To reduce the risk of infection, ensure the products are used according to the directions on the label.
The antiseptics in these single-use containers should be applied only one time to one patient.
We also recommend that health care professionals and patients do not dilute antiseptic products after opening them.
Applicators and any unused solution should be discarded after the single application.

[11/13/2013 - Drug Safety Communication - FDA]
[11/13/2013 - Questions and Answers - FDA]

Triad Alcohol Prep Pads, Alcohol Swabs, and Alcohol Swabsticks: Recall Due to Potential Microbial Contamination

Jun 8, 2011 | Audience: Pharmacy, Consumer, Risk Manager

[UPDATED 06/08/2011] Churchill Medical Systems, A Vygon Company, initiated a nationwide recall of certain lots of Skin-Prep Wipes used in Convenience Kits. The Skin-Prep Wipes were manufactured in the same facility as The Triad Group’s affected products.

[UPDATED 03/23/2011] Eli Lilly and Company notified customers not to use Prep Pads in black starter kits for Forteo [teriparatide (rDNA origin) injection].

[UPDATED 03/09/2011] Smith & Nephew issued a recall of IV PREP Antiseptic Wipes, manufactured for Smith & Nephew by The Triad Group.

[UPDATED 02/11/2011] Triad Alcohol Prep Pads are packaged with devices manufactured by Neuro Resource Group. The Triad alcohol prep pads should not be used.

[UPDATED 02/07/2011] Triad Alcohol Prep Pads are a component of Extavia (interferon beta 1-b) packaging marketed by Novartis. The Triad alcohol prep pads should not be used.

[UPDATED 02/05/2011] Triad Alcohol Prep Pads are a component of a convenience kit distributed with Watson’s Trelstar (triptorelin pamoate for injectable suspension) product. The Triad alcohol prep pads should not be used.

[UPDATED 02/01/2011] FDA reminded healthcare professionals about the safe use of non-sterile alcohol prep pads to clean and disinfect the surface of the skin.

[UPDATED 01/28/2011] Triad Alcohol Prep Pads may have been included in U.S. packaging for Arixtra Starter Kits manufactured by GlaxoSmithKline (GSK). The Triad alcohol prep pads should not be used.

[UPDATED 01/26/2011] Triad Alcohol Prep Pads are packaged for use with the kit presentation of Relistor (methylnaltrexone bromide) Subcutaneous Injection in the U.S. The Relistor vial and other components of the kit are not affected by the defective Triad alcohol pad. Relistor sold in single vials also is unaffected by this recall. Pfizer and Progenics advise patients using the Relistor kit not to use the Triad alcohol prep pads included in the Relistor packaging for 1 X 7 kits and 1 X 2 starter kits. When preparing to take their Relistor injection, patients should use an alcohol prep pad from a company other than Triad, or use a sterile gauze pad with isopropyl alcohol.

[UPDATED 01/21/2011] Triad alcohol prep pads packaged for use in the U.S. with Betaseron (interferon beta 1-b) should not be used by patients. There is no involvement or potential contamination of the Betaseron vial or other components in the Betaseron U.S. packaging. This issue is confined to the actual Triad alcohol prep products. Triad alcohol prep products are not used in Betaseron packaging outside of the United States. Bayer has halted shipments of Betaseron to its distribution network, until it can affect a replacement for the alcohol prep pad.

Bayer is instructing patients using Betaseron to immediately discontinue using the Triad alcohol prep pads included in the Betaseron packaging and dispose of those pads in the trash. When preparing to take their Betaseron injection, patients should use an alternative alcohol prep pad that is not subject to this Triad recall or use a sterile gauze pad in conjunction with isopropyl alcohol.

[UPDATED 01/14/2011] The Triad Group alcohol prep pads are co-packaged and distributed with Genentech medicines Boniva Injection, Fuzeon, Nutropin A.Q.Pen, Pegasys, and TNKase to customers in the United States. Genentech medicines are not contaminated and may continue to be used in accordance with the package insert. Patients and healthcare providers should not use the alcohol prep pads packaged with these medicines and should instead use an alternate alcohol prep pad that is not involved with the Triad Group recall.

[Posted 01/06/2011]

AUDIENCE: Pharmacy, Consumer, Risk Manager

ISSUE: Triad Group, a manufacturer of over-the-counter products and FDA notified healthcare professionals and patients of the recall involving all lots of alcohol prep pads, alcohol swabs, and alcohol swabsticks manufactured by Triad but sold as private labels at the consumer level. This recall has been initiated due to concerns about potential contamination of the products with Bacillus cereus. This recall involves those products marked as STERILE as well as non-sterile products. Use of contaminated alcohol prep pads, alcohol swabs, and alcohol swabsticks could lead to life-threatening infections, especially in at-risk populations, including immune suppressed and surgical patients.

BACKGROUND: Alcohol prep pads, alcohol swabs, and alcohol swabsticks are used to disinfect prior to an injection. They were distributed nationwide to retail pharmacies and are packaged in individual packets and sold in retail pharmacies in a box of 100 packets. The affected Alcohol Prep Pads, Alcohol Swabs and Alcohol Swabsticks can be identified by either "Triad Group," listed as the manufacturer, or the products are manufactured for a third party and use the names listed below in their packaging: Cardinal Health, PSS Select, VersaPro, Boca/ Ultilet, Moore Medical, Walgreens, CVS, Conzellin.

RECOMMENDATION: If a consumer has any of these types of products in their possession listing "Triad Group" as the manufacturer, they should not use the product and should return it to the place it was purchased for a full refund.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report Online: www.accessdata.fda.gov/scripts/medwatch/index.cfm
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

[06/08/2011 - Press Release - Churchill Medical Systems]
[03/17/2011 - Press Release - Eli Lilly]
[03/05/2011 - Press Release - Smith & Nephew]
[02/07/2011 - Press Release - Neuro Resource Group]
[01/10/2011 - Press Release - Novartis Pharmaceuticals]
[02/04/2011 - Press Release - Watson Pharmaceuticals]
[02/01/2011 - News Release - FDA]
[01/24/2011 - Press Release - GlaxoSmithKline]
[01/25/2011 - Press Release - Pfizer Inc. and Progenics Pharmaceuticals, Inc.]
[01/13/2011 - Press Release - Genentech]
[01/08/2011 - Press Release - Bayer HealthCare]
[01/06/2011 - Press Release - Triad Group]

Triad Alcohol Prep Pads, Alcohol Swabs, and Alcohol Swabsticks: Recall Due to Potential Microbial Contamination

Mar 23, 2011 | Audience: Pharmacy, Consumer, Risk Manager