Severity
Moderate
ModerateClass IITerminated
FDA Drug recall · Reported September 16, 2020
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
CGMP Deviations: Products manufactured at the same site were FDA testing found below the label claim for ethanol content and the presence of undeclared methanol.
Maquiladora Miniara Sa De Cv recalled Shine & Clean Hand Sanitizer gel, (Ethyl Alcohol 70%), 33.81 fl oz (1L) bottle, Made in M… - a moderate-severity action.
Shine & Clean Hand Sanitizer gel, (Ethyl Alcohol 70%), 33.81 fl oz (1L) bottle, Made in M… was recalled by Maquiladora Miniara Sa De Cv in September 16, 2020. Reason: CGMP Deviations: Products manufactured at the same site were FDA testing found below the label claim for etha…. Check the official notice for the remedy. Verify recall #D-1565-2020 with the FDA Drug before acting.
The recall
Maquiladora Miniara Sa De Cv issued this moderate-severity FDA Drug recall-CGMP Deviations: Products manufactured at the same site were FDA testing found below the label claim for etha….
- Moderate
- severity level
- Class II
- classification
- September 16, 2020
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-1565-2020 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-1565-2020) was formally reported on September 16, 2020, with the manufacturer initiating the action on July 9, 2020. It is classified under Moderate severity (Class II), with a current status of Terminated. Maquiladora Miniara Sa De Cv is listed as the recalling firm, operating out of Coyotepec. Federal records list the affected scope as 245,500 bottles.
The documented reason for this recall is: CGMP Deviations: Products manufactured at the same site were FDA testing found below the label claim for ethanol content and the presence of undeclared methanol. Distribution data in the federal record shows the product reached: Distributed Nationwide in the USA. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Children & Baby Products recalls over time
Where this recall sits in its category - 3,731 children & baby products recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
245,500 bottles
Related Recalls
6
0 from same agency
Product description
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
Reason for recall
CGMP Deviations: Products manufactured at the same site were FDA testing found below the label claim for ethanol content and the presence of undeclared methanol.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | D-1565-2020 |
| Date reported | September 16, 2020 |
| Date initiated | July 9, 2020 |
| Recalling firm | Maquiladora Miniara Sa De Cv |
| Firm location | Coyotepec |
| Affected scope | 245,500 bottles |
| Distribution | Distributed Nationwide in the USA |
Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (D-1565-2020) and product description against the item you own. Search the archive
- Confirm the current status with FDA Drug before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Maquiladora Miniara Sa De Cv. Units affected: 245,500 bottles.
Why was this product recalled? ▼
CGMP Deviations: Products manufactured at the same site were FDA testing found below the label claim for ethanol content and the presence of undeclared methanol.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on September 16, 2020. Severity: Moderate. Recall number: D-1565-2020.
Where was the recalled product distributed? ▼
Distribution: Distributed Nationwide in the USA.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-1565-2020) against your product. Visit the official FDA Drug website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Drug, reported September 16, 2020. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.