FDA recall D-0647-2022

AMS Packaging Inc · Class II · drug

Product

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.

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-0647-2022