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.
D-0646-2022
Product summary
- Event
- Event 89503
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 2,095,567 bottles
- Official record key
drug-enforcement:D-0646-2022
Official wording
Reason: Subpotent Drug: FDA analysis has revealed some bottles of these products were sub potent for ethanol.
Code information: All lots within expiry and labelled as 'Made in the USA'
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Potency or specification failure
Subpotent