FDA recall D-0994-2019

Petra Hygienic Systems Int Ltd · Class III · 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.

Reason for recall

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

Distribution

Nationwide in the USA.

Key facts

Status
Terminated
Initiation date
2019-03-04
Report date
2019-03-13
Termination date
2020-12-10
Voluntary/Mandated
Voluntary: Firm initiated
Location
Concord, N/A, Canada

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0994-2019