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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 89503

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
January 28, 2022
Product types
Drug
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
AMS Packaging Inc

Dossier provenance

Source snapshots represented here

  • openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 2

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
Recall number
D-0646-2022
Initiated
January 28, 2022
Classification
Class II
Status
Ongoing
Recalling firm
AMS Packaging Inc
Quantity
2,095,567 bottles

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Subpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

drug · product 2 of 2

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.

D-0647-2022
Recall number
D-0647-2022
Initiated
January 28, 2022
Classification
Class II
Status
Ongoing
Recalling firm
AMS Packaging Inc
Quantity
487,000 bottles

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Subpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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