May 2023 FDA Recall Drug by Alpha Aromatics
D-0760-2023 - CGMP Deviations

This Class II drug recall was voluntarily initiated by Alpha Aromatics on May 16, 2023 for the product Drug. The FDA reported the reason for recall as cgmp deviations. The product was distributed in Product was distributed to one account in NC. and the recall is currently terminated.

Recall Number: D-0760-2023

Reason for Recall
CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits.
Initiated
05-16-2023
Reported
05-31-2023
Quantity
544 1 gallon bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
92347
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.
Alpha Aromatics
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.
Product was distributed to one account in NC.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-01-2024
Product Description About Product Description
Full technical description of the product.
FOAMING HAND SANITIZER, fresh mint scent, 62% alcohol, 1 Gallon / 3.78 Liters bottle, 290 Alpha Drive RIDC industrial Park, Pittsburgh, PA 15238,

Batch or Lot Expiration Information

Lot# Lot: 2020-013211 and 2020-013629, No EXP date on label.