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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 86063

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
July 09, 2020
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Maquiladora Miniara Sa De Cv

Dossier provenance

Source snapshots represented here

  • openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 1

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

D-1565-2020
Recall number
D-1565-2020
Initiated
July 09, 2020
Classification
Class II
Status
Terminated
Quantity
245,500 bottles

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
presence of undeclared methanol
Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

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.

Code information

Lots: 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.

Distribution pattern

Distributed Nationwide in the USA

Field note

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