Drug product
Premium Nature Instant Hand Sanitizer, (ethyl alcohol 65%), 8 oz/ 236 ML plastic bottles; Premium Nature, South Plainfield, NJ. UPC 819192028668
D-1148-2022
Product summary
- Event
- Event 90152
- Status
- Ongoing
- Classification
- Class II
- Quantity
- unknown
- Official record key
drug-enforcement:D-1148-2022
Official wording
Reason: Subpotent Drug: FDA analysis has revealed some bottles of these products were sub potent for ethanol.
Code information: all lots
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Potency or specification failure
Subpotent