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High RiskFDAfda-D-1565-2020UNDECLARED ALLERGEN

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. Carre...

Units Affected
245,500
Recall Date
July 9, 2020
Issuing Agency
Hazard
Undeclared Allergen

FDA Recall Notice

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-D-1565-2020.

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.

Corrective Action (per FDA)

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-D-1565-2020.

Recall terminated by FDA.

🩺 Talk to your doctor or pharmacist

Product Recall Tracker does not provide medical advice. Any specific instructions about this medication or device come directly from the FDA notice above. Before making any change to your treatment:

  1. Do not stop, change, or discard your prescription on your own.
  2. Call your doctor or pharmacist and ask whether this FDA notice applies to your prescription (have the brand name, dosage, and lot number ready if you can find them).
  3. Follow your clinician's guidance on whether to continue, switch, or return the product.
  4. If you have experienced a reaction, seek medical care and report it to the FDA via MedWatch.
  5. For the official FDA notice, visit the FDA recalls page.

Consumer Contact (per FDA)

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-D-1565-2020.

Maquiladora Miniara Sa De Cv

FDA

About the U.S. Food and Drug Administration

The FDA regulates drugs, medical devices, food, cosmetics, and tobacco. Adverse event reports and recall notices are the main public safety signal.

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📣 Report an adverse event to the FDA (MedWatch)

If you had an adverse reaction, side effect, or device malfunction from this medication or device, report it to the FDA through MedWatch. Talk to your doctor or pharmacist first — do not stop a prescription on your own. Reports help the FDA detect rare or emerging safety signals and can lead to label changes or recalls.

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Maquiladora Miniara Sa De Cv Recall FAQ

Maquiladora Miniara Sa De Cv is the subject of a topical drugs safety report: 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. Carre.... The notice was published on July 9, 2020 by the U.S. Food and Drug Administration (FDA). Approximately 245,500 units are potentially affected.