D-0646-2022 Class II Ongoing

Recalled by AMS Packaging Inc — South Plainfield, NJ

Recall Details

Product Type
Drugs
Report Date
March 2, 2022
Initiation Date
January 28, 2022
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2,095,567 bottles

Product Description

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 Pattern

Nationwide in the USA

Code Information

All lots within expiry and labelled as 'Made in the USA'