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Recall Observatory FDA recall evidence

Drug product

BORN BASIC., ANTI-BAC HAND SANITIZER, 70% Alcohol, (Ethyl Alcohol 70%), packaged as a) 9.5 FL OZ (280 mL) bottle, UPC 8 40038 21462 4: b) 16.9 FL OZ (500 mL) bottle, UPC 8 40038 21456 3; and c) 34 FL OZ (1L) bottle, UPC 8 40038 21447 1; Made in Mexico; Distributed by Scent Theory Products, LLC, New York, NY 10018.

D-1581-2020

July 23, 2020

Class II

Product summary

Firm
Real Clean Distribuciones SA de CV
Event
Event 86105
Status
Terminated
Classification
Class II
Quantity
975,720 bottles
Official record key
drug-enforcement:D-1581-2020

Official wording

Reason: CGMP Deviations: Born Basic Anti Bac was found to be below the label claim for ethanol content and contained methanol. Other products were recalled because they were manufactured in the same facility as the product found to contain methanol.

Code information: Lots: a) 0133720, 0233720 b) 0833420, 0933420, 1333420, 1433420, 1533420, 1633420, 1733420, 1833420, 1933420, 2033420, 2133420, 2633420, 2733420, 2833420, 2933420 c) 0133420, 0233420, 0333420, 0433420, 0533420, 0633420

Distribution pattern: Distributed Nationwide in the USA

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    found to contain methanol
  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations