Exact FDA event identifier

Event 90152

1 recalled-product record grouped only because every row carries this exact official event ID.

Event summary

Timeline bucket: May 10, 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

Device root-cause evidence is not applicable to this event. No grouped product has the official product type device; this is not an unavailable-enrichment finding.

Complete imported group

Every recalled product in this event

1 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 1

Premium Nature Instant Hand Sanitizer, (ethyl alcohol 65%), 8 oz/ 236 ML plastic bottles; Premium Nature, South Plainfield, NJ. UPC 819192028668

D-1148-2022

Recall number: D-1148-2022
Initiated: May 10, 2022
Classification: Class II
Status: Ongoing
Recalling firm: AMS Packaging Inc
Quantity: unknown

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

Distribution pattern

Nationwide in the USA