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  4. Maquiladora Miniara S.A. de C.V. Issues Voluntary Nationwide Recall of Shine and Clean Hand Sanitizer and Due to Potential Presence of Undeclared Methanol (Wood Alcohol)
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COMPANY ANNOUNCEMENT

Maquiladora Miniara S.A. de C.V. Issues Voluntary Nationwide Recall of Shine and Clean Hand Sanitizer and Due to Potential Presence of Undeclared Methanol (Wood Alcohol)

When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.

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Summary

Company Announcement Date:
FDA Publish Date:
Product Type:
Drugs
Reason for Announcement:
Recall Reason Description
Potential presence of methanol (wood alcohol)
Company Name:
Maquiladora Miniara, S.A. de C.V.
Brand Name:
Brand Name(s)
Shine & Clean
Product Description:
Product Description
Hand Sanitizer Gel

Company Announcement

Maquiladora Miniara S.A. de C.V. is voluntarily recalling lots of Shine and Clean Hand Sanitizer gel to the consumer level. The products are being recalled due to the potential presence of methanol (wood alcohol)

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 Maquiladora Miniara S.A. de C.V. has not received any reports of adverse events related to this recall.

These products are used as topical hand sanitizers. The affected Shine and Clean Hand Sanitizer Gel is packaged in 1000 ml bottles and 1-gallon containers. Lot numbers:

F200829088/F200829095/F200829107/D202728743/D202528742/D202428733/D202728743/
D2028753/D202528742/D202428733/ D202028689/ D201828660/ D202428734/E200128784/E200418795/
D202428734/D202828689/D201828660/E201628912/E201628913/E201628911/E201528902/E201528903/
E201628910/E201628918/E201628914/E201628915/E201628916/E201628917/ E202328969/E202428975/
E202528981 /E202128947/ E201728918/E201728919/E201428876/ E201828894/ E201828920/
E201428876/E201128850/E201328859/E200628817/E200828826/E200928840/D202128699/D202428700.

Shine and Clean Hand Sanitizer gel were distributed Nationwide to retail stores via distributors.

Maquiladora Miniara S.A. de C.V. is notifying its distributors and customers by e-mail and is arranging for return of all recalled products. Distributors that have Shine and Clean Hand Sanitizer which is being recalled, should stop using and distributing product and contact their clients.

Consumers who have questions about this recall can contact Maquiladora Miniara S.A. de C.V. By +52 55 33871987 + 52 55 8394 5857 or Hector.carrillo@miniara.com.mx the hours are available from 10:00 a.m. to 1:00 p.m. and from 2:00 p.m. to 4:00 p.m. Consumers should contact their doctor or healthcare provider if they have experienced any problems related to taking or using this medicine.

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.

Link to FDA's update


Company Contact Information

Consumers:
Maquiladora Miniara S.A. de C.V.
+52 55 33871987
Media:
Héctor Carrillo
+52 55 33871987
Hector.carrillo@miniara.com.mx

Product Photos

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