Petra Hygienic Systems Recalls Athleticare Hand Soap Due to Triclosan
Petra Hygienic Systems is recalling Athleticare Anti-Bacterial Hand Soap because it contains triclosan, an ingredient no longer permitted in over-the-counter antiseptic wash products.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this as a Class III recall, which is defined as a situation where use of or exposure to a violative product is not likely to cause adverse health consequences.
Plain-English summary
Petra Hygienic Systems Int Ltd is recalling Athleticare Anti-Bacterial Hand Soap AC 550 (triclosan), 0.25%, 4 litres/1.1 US Gallon bottles. The product is packaged in cases of four bottles. The recall involves 58 cases distributed nationwide in the USA.
The recall was initiated because the product contains triclosan, an ingredient that can no longer be contained in over-the-counter consumer antiseptic or antibacterial wash products. This means the product does not meet the current FDA monograph requirements for these types of products.
Consumers who have purchased this product should stop using it and return it to the place of purchase for a refund or contact the recalling firm for further instructions.
The recalled product
- Product
- ATHLETICARE Anti-Bacterial Hand Soap AC 550 (triclosan), 0.25%, 4 litres/1.1 US Gallon bottles, packaged in 4 x 4 Litres/1.1 US gallons per case, Petra Hygienic Systems, Concord, ON L4K 4RS/ Reno, NV 89511, NDC 42326-550-01, UPC 0 65936 10335 5.
- Manufacturer
- Petra Hygienic Systems Int Ltd
- Category
- Drug — OTC Antiseptic
- Hazard
- Affected units
- 58
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)
- All Lots
Distribution
Distributed nationwide across the United States.
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