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.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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
- Manufacturer
- Maquiladora Miniara Sa De Cv
- Category
- Drug — Hand Sanitizer
- Hazard
- 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.
Related recalls
Same hazard · methanol
See all →- High
- CriticalFDA Recalls Alcoholada Gel Pain Reliever Over Methanol Contamination
FDA (Drugs) · 2024-05-01
- SevereHand sanitizer recalled nationwide for methanol contamination
FDA (Drugs) · 2023-06-21
- SevereHand Sanitizer Containing Methanol Recalled Due to Chemical Contamination
FDA (Drugs) · 2023-06-21
- CriticalHand Sanitizer Recalled for Methanol and Acetaldehyde Contamination
FDA (Drugs) · 2023-03-15
Similar recalls
- SevereHand Sanitizer Gel Recalled for Methanol Contamination and Low Ethanol
FDA (Drugs) · 2021-09-08
- SevereMEDICALLY MINDED Hand Sanitizer Gel Recalled for Methanol Contamination
FDA (Drugs) · 2021-09-08
- CriticalHand sanitizer recalled for methanol contamination and insufficient ethanol
FDA (Drugs) · 2022-08-24
- SevereScent Theory Hand Sanitizer Recalled for Methanol Contamination
FDA (Drugs) · 2020-09-23
- SevereHand Sanitizer Recalled for Methanol Contamination and Low Ethanol Content
FDA (Drugs) · 2020-11-25
- SevereHand Sanitizer Gel Recalled Due to Methanol Contamination Risk
FDA (Drugs) · 2021-09-08