Drug Enforcement D-0338-2024

CGMP Deviations

Status

Terminated

Classification

Class II

Report Date

February 28, 2024

Termination Date

August 14, 2024

Product Information

Product description
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.
Product quantity
676 gallons
Reason for recall
CGMP Deviations
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Product was distributed to two accounts in NC and MI

Location & Firm

Recalling firm
Alpha Aromatics
Address
294 Alpha Dr, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0338-2024
Event ID
93880
Recall initiation date
January 25, 2024
Center classification date
February 16, 2024
Code info
Lot # 2022-012884 Lot # 2023-002020 Lot # 2023-003532 Lot # 2023-003761
More code info
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