March 2021 FDA Recall Drug by Pnhc, Llc.
D-0365-2021 - Labeling Not Elsewhere Classified

This Class I drug recall was voluntarily initiated by Pnhc, Llc. on March 10, 2021 for the product Drug. The FDA reported the reason for recall as labeling not elsewhere classified. The product was distributed in FL, CA and the recall is currently terminated.

Recall Number: D-0365-2021

Reason for Recall
Labeling Not Elsewhere Classified: Hand sanitizer packaged in containers resembling drinking water bottles.
Initiated
03-10-2021
Reported
05-12-2021
Quantity
139,806 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87531
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.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
PNHC, 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.
FL, CA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-16-2023
Product Description About Product Description
Full technical description of the 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.

Batch or Lot Expiration Information

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