FDA-Drug2022-03-02Class II

Premium Nature Instant Hand Sanitizer, (ethyl alcohol 70%), plastic bottle packaged as (a) 8 OZ, UPC 8 19192 02866 8; (b) 16 OZ, UPC 8 19192 02874 3; 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
487,000 bottles
Manufactured in
161 Helen St, South Plainfield, NJ, United States
Products
Premium Nature Instant Hand Sanitizer, (ethyl alcohol 70%), plastic bottle packaged as (a) 8 OZ, UPC 8 19192 02866 8; (b) 16 OZ, UPC 8 19192 02874 3; Premium Nature, South Plainfield, NJ.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0647-2022

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