FDA recall D-1148-2022

AMS Packaging Inc · Class II · drug

Product

Premium Nature Instant Hand Sanitizer, (ethyl alcohol 65%), 8 oz/ 236 ML plastic bottles; Premium Nature, South Plainfield, NJ. UPC 819192028668

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
2022-05-10
Report date
2022-06-22
Voluntary/Mandated
Voluntary: Firm initiated
Location
South Plainfield, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1148-2022