Nuevo Leon, Mexico Sep 19, 2020 (Issuewire.com) - Harmonic Nature Issues Voluntary Nationwide Recall of Alcohol Antiseptic 75% Topical Solution Hand Sanitizer 8.45 Fl Oz (250 mL) Due to the Presence of 1-Propanol
Company Contact: HARMONIC NATURE S. DE R.L. Mi
Name: Miguel Isaac Martinez Marina
Phone Number: +956 438 5436 Name on the label: Alcohol Antiseptic 75% Topical Solution Hand Sanitizer 8.45 Fl Oz (250 mL)
Harmonic Nature is voluntarily recalling all lots of Alcohol Antiseptic 75% Topical Solution Hand Sanitizer 8.45 Fl Oz (250 mL), product shipped to the US (6/02/2020) 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 an 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 the 2400 bottles at the US custom bróker, Aquiles INC.
Harmonic Nature is notifying Aquiles INC. Currently, Aquiles INC has the 2400 bottles of Alcohol Antiseptic 75% Topical Solution Hand Sanitizer 8.45 Fl Oz (250 mL), in his warehouse and is arranging for the return of all recalled product. Consumers with questions regarding this recall can contact Harmonic Nature by +956 438 5436 or miguel_martinez2000@yahoo.com Monday to Friday from 8:00 am to 6:00 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: fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form fda.gov/MedWatch/getforms.htmor 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.
Media Contact
Miguel Isaac Martinez Marina miguel_martinez2000@yahoo.com 956438546 4712 N 12Th St suite 47 McAllen Tx.
