November 2021 FDA Recall Drug by American Screening Llc
D-0266-2022 - Labeling Not Elsewhere Classified

This Class I drug recall was voluntarily initiated by American Screening Llc on November 19, 2021 for the product Drug. The FDA reported the reason for recall as labeling not elsewhere classified. The product was distributed Nationwide and the recall is currently completed.

Recall Number: D-0266-2022

Reason for Recall
Labeling Not Elsewhere Classified: Hand sanitizer packaged in containers resembling drinking water bottles.
Initiated
11-19-2021
Reported
12-15-2021
Quantity
153,336 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89075
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
American Screening LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distributed Nationwide in the USA
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

Lot# 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.