FDA recall D-0646-2022

AMS Packaging Inc · Class II · drug

Product

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.

Reason for recall

Subpotent Drug: FDA analysis has revealed some bottles of these products were sub potent for ethanol.

Distribution

Nationwide in the USA

Key facts

Status
Ongoing
Initiation date
2022-01-28
Report date
2022-03-02
Voluntary/Mandated
Voluntary: Firm initiated
Location
South Plainfield, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0646-2022