D-0338-2024 Class II Terminated

Recalled by Alpha Aromatics — Pittsburgh, PA

FDA drug recall D-0338-2024 was initiated by Alpha Aromatics on January 25, 2024 and is designated Class II. Reason for recall: CGMP Deviations The recall status is terminated (terminated August 14, 2024). Affected quantity: 676 gallons.

Recall Details

Product Type
Drugs
Report Date
February 28, 2024
Initiation Date
January 25, 2024
Termination Date
August 14, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
676 gallons

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.

Reason for Recall

CGMP Deviations

Distribution Pattern

Product was distributed to two accounts in NC and MI

Code Information

Lot # 2022-012884 Lot # 2023-002020 Lot # 2023-003532 Lot # 2023-003761