FDA-Drug2022-03-02Class II
Premium Nature Instant Hand Sanitizer, (ethyl alcohol 65%), plastic bottles packaged as (a) 2 OZ / 60ML, UPC 8 19192 02865 1; (b) 4 OZ, 118 ML, UPC 8 19192 02826 2; (c) 16 OZ, 473 ML, UPC 8 19192 02874 3; (d) 1 gallon, UPC 8 19192 02830 9; Premium Nature, South Plainfield, NJ.
AMS Packaging Inc
Hazard
Subpotent Drug: FDA analysis has revealed some bottles of these products were sub potent for ethanol.
Sold states
Nationwide in the USA
Affected count
2,095,567 bottles
Manufactured in
161 Helen St, South Plainfield, NJ, United States
Products
Premium Nature Instant Hand Sanitizer, (ethyl alcohol 65%), plastic bottles packaged as (a) 2 OZ / 60ML, UPC 8 19192 02865 1; (b) 4 OZ, 118 ML, UPC 8 19192 02826 2; (c) 16 OZ, 473 ML, UPC 8 19192 02874 3; (d) 1 gallon, UPC 8 19192 02830 9; Premium Nature, South Plainfield, NJ.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0646-2022Don't want to check this manually?
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