The Recall Desk

FDA (Drugs) recall action 89503

AMS Packaging Inc recalled 2 products on 2022-03-02

The FDA (Drugs) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2022-03-02
Critical
0
Units
2,582,567

Why these products were recalled

Subpotent Drug: FDA analysis has revealed some bottles of these products were sub potent for ethanol.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–2 of 2

  • ModerateFDA (Drugs)··2022-03-02

    Premium Nature Instant Hand Sanitizer Recalled for Subpotent Ethanol

    AMS Packaging Inc is recalling Premium Nature Instant Hand Sanitizer (70% ethyl alcohol) in 8 oz and 16 oz bottles because some bottles contain less ethanol than labeled, reducing effectiveness.

    Product
    Premium Nature Instant Hand Sanitizer, (ethyl alcohol 70%), plastic bottle packaged as (a) 8 OZ, UPC 8 19192 02866 8; (b) 16 OZ, UPC 8 19192 02874 3; Premium Nature, South Plainfield, NJ.
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2022-03-02

    Premium Nature Instant Hand Sanitizer Recalled for Subpotent Ethanol Content

    Premium Nature Instant Hand Sanitizer is being recalled nationwide because some bottles were found to contain subpotent levels of ethanol. The FDA identified the issue during analysis of multiple bottle sizes.

    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.
    Category
    Distribution
    0 states