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Recall Observatory FDA recall evidence

Drug product

AmericanScreening HAND SANITIZER (ethyl alcohol 70%) ANTIMICROBIAL FORMULA Vitamin E & Moisturizer, 8 FL OZ (237 mL) bottle with either a black or clear top, Distributed by American Screening LLC Shreveport, LA, 71106 UPC 8 40050 51579 2

D-0266-2022

November 19, 2021

Class I

Product summary

Firm
American Screening LLC
Event
Event 89075
Status
Completed
Classification
Class I
Quantity
153,336 bottles
Official record key
drug-enforcement:D-0266-2022

Official wording

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

Code information: Black capped bottles have no lot numbers but include expiration dates of 5/21/2022 and 05/24/2022. Clear capped bottles have neither lot numbers nor expiration dates.

Distribution pattern: Distributed Nationwide in the USA

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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