Multi-event August 2020 FDA Recall Drug by Open Book Extracts

This Multi-event Class II drug recall was voluntarily initiated by Open Book Extracts on August 7, 2020 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 terminated.

Reported Recall Events

D-1563-2020 TERMINATED D-1564-2020 TERMINATED

Recall Number: D-1563-2020

Reason for Recall
Labeling Not Elsewhere Classified: Product labeled to contain methanol
Initiated
08-07-2020
Reported
09-16-2020
Quantity
340,000 packs

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
86251
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Open Book Extracts
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.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-22-2022
Product Description About Product Description
Full technical description of the product.
Always Be Clean Hand Sanitizer (73% Alcohol) 0.04 FL OZ (1.2 mL) packaged in a) Single snaps (NDC 75091-2020-1 UPC 375091202016); b) 100-count boxes (NDC 75091-2020-2 UPC 375091202023); c) 25-count boxes (NDC 75091-2020-3 UPC 375091202030)

Batch or Lot Expiration Information

Lot# ES8-200514

Recall Number: D-1564-2020

Reason for Recall
Labeling Not Elsewhere Classified: Product labeled to contain methanol
Initiated
08-07-2020
Reported
09-16-2020
Quantity
2880 boxes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
86251
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Open Book Extracts
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.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-22-2022
Product Description About Product Description
Full technical description of the product.
Just Hand Sanitizer (Ethyl Alcohol 73%) Single Use-Packs 100-count NDC 78065-2020-2 UPC 703123998598 (Single packs NDC 78065-2020-1 UPC 703123998659) Distributed by: Just Hand Sanitizer

Batch or Lot Expiration Information

Lot# Lot: ES9-200610