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- Soluciones Cosméticas Issues Voluntary Nationwide Recall of Bersih Hand Sanitizer Gel Due to The Potential Presence of Undeclared Methanol (Wood Alcohol): Updated August 7, 2020
Soluciones Cosméticas Issues Voluntary Nationwide Recall of Bersih Hand Sanitizer Gel Due to The Potential Presence of Undeclared Methanol (Wood Alcohol): Updated August 7, 2020
Summary
Company Announcement Date:
August 09, 2020
FDA Publish Date:
August 09, 2020
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 voluntary recalled 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). This release provides additional information about the packaging for the recalled products.
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.
The product is used as a hand sanitizer and is packaged in 16.9 ounce plastic clear bottles with blue tops or green tops with UPC Codes 816822026667 or 7503007103178. The lot numbers range from 0100K01 to 0148K01. This product was distributed nationwide to wholesale distributors and retailers.
Soluciones Cosméticas is notifying its distributors by voluntary recall letter and consumers via this press release. Consumers that have the product subject to this recall should stop using and either contact Soluciones Cosméticas per the below for disposal instructions or return it to the place of purchase.
Consumers with questions regarding this recall can contact Soluciones Cosméticas at 866-912-8410 Monday through Friday 8am to 5pm Eastern Time or by email at bersihrecall6551@stericycle.com. 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 formor 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 updates on hand sanitizers consumers should not use.
Company Contact Information
Consumers:
Soluciones Cosméticas
866-912-8410
bersihrecall6551@stericycle.com
Media:
Ignacio Puerto
+52 55 999 163 5838
ipuerto@solucionescosmeticas.com.mx
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* We believe that none of the product being recalled were processed or offered through the national office
* We strongly encourage you to notify your agencies within one business day from receipt of this notice.
* ALL cased and uncased inventories, both at the member level and agency level, need to be checked. This product may have entered member and agency warehouses through salvage, local donations, TEFAP, local purchases, retail pickups, food drives, or other avenues.
* For additional local details, please contact the Health Department(s) for the area(s) your food bank serves.
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About Feeding America Recall Notices
The Feeding America national office issues notifications of all national Class I and II recalls–those involving a health hazard situation in which there is reasonable probability that eating the food will cause health problems or death–and other recalls that may affect the safety of food supplied to network members.
The national office strongly encourages all member product solicitors, operations managers, and others involved in food and grocery distribution to regularly consult resources provided by the United States Food and Drug Administration (FDA) at https://www.fda.gov/opacom/7alerts.html, and the United States Department of Agriculture (USDA) at https://www.fsis.usda.gov/Fsis_Recalls/index.asp. Additionally, members can often receive information on national, state, and local recalls by contacting their local health departments.