Pure Care Foaming Mint Hand Sanitizer recalled for manufacturing deviations
Pure Care Foaming Mint Hand Sanitizer has been voluntarily recalled due to manufacturing process deviations. The product was distributed to accounts in North Carolina and Michigan.
The agency’s classification
FDA (Drugs): Class II
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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II voluntary recall initiated due to CGMP deviations (manufacturing process violations). No illnesses or injuries have been reported. Per the rubric, voluntary precautionary recalls without reported hospitalizations or specific identified hazards score as Moderate (2).
Plain-English summary
Pure Care Foaming Mint Hand Sanitizer 62% (NDC 75009-562), manufactured by Alpha Aromatics and distributed by Air Scent International, has been voluntarily recalled. The affected lots (2022-012884, 2023-002020, 2023-003532, and 2023-003761) totaling 676 gallons were distributed to two accounts in North Carolina and Michigan.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations discovered during manufacturing. These process violations raise concerns about product quality and integrity, though no illnesses or injuries have been reported.
If you have this product, discontinue use and contact Air Scent International at 290 Alpha Drive, Pittsburgh, PA 15238 or visit www.airscent.com for return or disposal instructions. The recall was initiated on January 25, 2024, and terminated on August 14, 2024.
The recalled product
- 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.
- Manufacturer
- Alpha Aromatics
- Category
- Drug
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot # 2022-012884 Lot # 2023-002020 Lot # 2023-003532 Lot # 2023-003761
Distribution
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