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Recall Observatory FDA recall evidence

Drug product

scent theory KEEP CLEAN Moisturizing Hand Sanitizer, 70% alcohol (Ethyl Alcohol 70%), 16.9 FL OZ/500 mL bottle, Distributed by Scent Theory Products, LLC New York, NY 10018. Made in Mexico, UPC 8 40038 21434 1

D-1580-2020

July 23, 2020

Class II

Product summary

Firm
Real Clean Distribuciones SA de CV
Event
Event 86105
Status
Terminated
Classification
Class II
Quantity
917,280 bottles
Official record key
drug-enforcement:D-1580-2020

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: 1633220, 1733220, 1833220, 1933220, 2033220, 2133220, 2233220, 2333220, 2433220, 2533220, 2633220, 2733220, 2833220, 2933220, 3033220, 3133220, 3233220, 3333220, 3433220, 3533220, 3633220, 3733220, 3833220, 3933220, 4033220, 4133220

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