Pure Care Foaming Mint Hand Sanitizer 62%, Distributed by: Air Scent International, 290 Alpha Drive, RIDC Industrial Par
Summary
The FDA issued a Class II for Pure Care Foaming Mint Hand Sanitizer 62%, Distributed by: Air Scent Internation by Alpha Aromatics. Reason: CGMP Deviations.
Details
Source
Drug Recall
External ID
D-0338-2024
Action Date
2024-02-28
Status
Terminated
Category
drug
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.
Lot/Code Info: Lot # 2022-012884 Lot # 2023-002020 Lot # 2023-003532 Lot # 2023-003761
Quantity Affected: 676 gallons
Reason for Recall
CGMP Deviations
Distribution
Product was distributed to two accounts in NC and MI
Type: Voluntary: Firm initiated
Recall Initiated: 2024-01-25
Company
Pittsburgh, PA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 41 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Alpha Aromatics has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Alpha Aromatics) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Alpha Aromatics have FDA actions?
Alpha Aromatics has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0338-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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