The Recall Desk
SevereFDA (Drugs)·D-1565-2020·Announced 2020-09-16

Shine & Clean Hand Sanitizer Recalled for Methanol and Low Ethanol

Maquiladora Miniara S.A. de C.V. is recalling Shine & Clean Hand Sanitizer gel because FDA testing found undeclared methanol and ethanol levels below the label claim.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II and involves the presence of undeclared methanol, a significant hazard that can cause serious injury or death, meeting the criteria for a Severe rating.

Plain-English summary

Maquiladora Miniara S.A. de C.V. is recalling Shine & Clean Hand Sanitizer gel, (Ethyl Alcohol 70%), 33.81 fl oz (1L) bottles. The product was manufactured in Mexico and distributed nationwide in the USA. The recall involves 245,500 bottles across multiple lots.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. FDA testing of products manufactured at the same site revealed that the ethanol content was below the label claim and that undeclared methanol was present.

Consumers who have this product should stop using it and follow the instructions provided by the recalling firm or the FDA for disposal or return.

The recalled product

Product
Shine & Clean Hand Sanitizer gel, (Ethyl Alcohol 70%), 33.81 fl oz (1L) bottle, Made in Mexico By: Maquiladora Miniara S.A. de C.V. Carrerera Teoloyucan Huehuetoca km: 22 S/N La Planada Mexico C.P.: 54665 NDC 76753-001-01
Affected units
245,500

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Lots: F200829088
  • F200829095
  • F200829107
  • D202728743
  • D202528742
  • D202428733
  • D2028753
  • D202028689
  • D201828660
  • D202428734
  • E200128784
  • E200418795
  • D202828689
  • E201628912
  • E201628913
  • E201628911
  • E201528902
  • E201528903
  • E201628910
  • E201628918

Distribution

Distributed nationwide across the United States.