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Recall Observatory FDA recall evidence

Drug 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.

D-0994-2019

March 04, 2019

Class III

Product summary

Firm
Petra Hygienic Systems Int Ltd
Event
Event 82283
Status
Terminated
Classification
Class III
Quantity
58 cases
Official record key
drug-enforcement:D-0994-2019

Official wording

Reason: Does Not Meet Monograph: product contains, triclosan, an ingredient that can no longer be contained in over-the-counter consumer antiseptic/antibacterial wash products.

Code information: All Lots

Distribution pattern: Nationwide in the USA.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Does Not Meet Monograph: product contains, triclosan, an ingredient that can no longer be contained in over-the-counter consumer antiseptic/antibacterial wash products.