D-0646-2022 Class II Ongoing
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'