Class II · Moderate risk
Unison Hand Care Products
CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.
ATHLETICARE Anti-Bacterial Hand Soap AC 550
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Does Not Meet Monograph: product contains, triclosan, an ingredient that can no longer be contained in over-the-counter consumer antiseptic/antibacterial wash products.
Cause type: Unapproved drug
The product was marketed without an approved NDA/ANDA, or does not meet the OTC monograph it claims to follow. Nothing about the product - dose, purity, safety - has been reviewed by FDA, so the claims on the box are unverified. All unapproved drug recalls.
What was recalled
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.
Affected NDC
42326-0550-01
Compare with the code on your package — it is the most precise check available.
Drug: Triclosan
- Recalling firm
- Petra Hygienic Systems Int Ltd
- NDC code
- 42326-550-01
- Origin
- N/A, Canada
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0994-2019 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Triclosan recalls
See all
Class II · Moderate risk
Kindest Kare Antimicrobial Foaming Handwash
Labeling: Not Elsewhere Classified; Incorrect/Undeclared Excipients: Outdated previous version of label applied to products that incorrectly states one inactive ingredient.
Class II · Moderate risk
REEVA (triclosan)
Microbial Contamination of a Non-Sterile Products: Product was found to be contaminated with the bacteria, Sarcina Lutea.
Other unapproved drug recalls from 2019
All unapproved drug recalls
Class I · High risk
Panther Platinum 30000 Capsules
Marketed without an Approved NDA/ANDA; FDA analysis found product to contain tadalfil
Class I · High risk
Rhino 7 Platinum 30000 Capsules
Marketed without an Approved NDA/ANDA; FDA analysis found product to contain tadalfil
Class I · High risk
Stallion Platinum 30000 Capsules in blue
Marketed without an Approved NDA/ANDA; FDA analysis found product to contain tadalfil
Class I · High risk
Bull Platinum 30000 Capsules
Marketed without an Approved NDA/ANDA; FDA analysis found product to contain tadalfil
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