January 2024 FDA Recall Drug by Alpha Aromatics
D-0338-2024 - CGMP Deviations
This Class II drug recall was voluntarily initiated by Alpha Aromatics on January 25, 2024 for the product Drug. The FDA reported the reason for recall as cgmp deviations. The product was distributed in Product was distributed to two accounts in NC and MI and the recall is currently terminated.
Recall Number: D-0338-2024
CGMP Deviations
01-25-2024
02-28-2024
676 gallons
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
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.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Product was distributed to two accounts in NC and MI
08-14-2024
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Pure Care Foaming Mint Hand Sanitizer 62%, Distributed by: Air Scent International, 290 Alpha Drive, RIDC Industrial Park, Pittsburg, PA 15238 USA, www.airscent.com, NDC 75009-562.
Batch or Lot Expiration Information
Lot# 2022-012884
Lot# 2023-002020
Lot# 2023-003532
Lot# 2023-003761
