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Recall Observatory FDA recall evidence

Drug product

heal the world, moisturizing original hand sanitizer, Non-Sterile Solution, Alcohol Antiseptic, 70% Topical Solution, 9.6 FL OZ. (285 mL) bottle, Heal The World, LLC, Draper, UT 84020, UPC 6 19988 44038 0.

D-0365-2021

March 10, 2021

Class I

Product summary

Firm
PNHC, LLC.
Event
Event 87531
Status
Terminated
Classification
Class I
Quantity
139,806 bottles
Official record key
drug-enforcement:D-0365-2021

Official wording

Reason: Labeling Not Elsewhere Classified: Hand sanitizer packaged in containers resembling drinking water bottles.

Code information: Lots: SAA21, SAA24, SAA27, SAA22, SAA23, SAA29, SAA26, SAA28, SAA25, SAA32, SAA55, SAA56, SAA44, SAA60, expiration 5/2022

Distribution pattern: FL, CA

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Labeling Not Elsewhere Classified: Hand sanitizer packaged in containers resembling drinking water bottles.