February 14, 2023
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 [email protected]. 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.
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Original Source: https://www.drugs.com/fda/nanomaterials-discovery-corporation-issues-voluntary-nationwide-recall-alcohol-antiseptic-80-14584.html