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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 82283

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

Open FDA event record

Event summary

Timeline bucket
March 04, 2019
Product types
Drug
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Petra Hygienic Systems Int Ltd

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

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

ATHLETICARE Anti-Bacterial Hand Soap AC 550 (triclosan), 0.25%, 4 litres/1.1 US Gallon bottles, packaged in 4 x 4 Litres/1.1 US gallons per case, Petra Hygienic Systems, Concord, ON L4K 4RS/ Reno, NV 89511, NDC 42326-550-01, UPC 0 65936 10335 5.

D-0994-2019
Recall number
D-0994-2019
Initiated
March 04, 2019
Classification
Class III
Status
Terminated
Quantity
58 cases

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Does Not Meet Monograph: product contains, triclosan, an ingredient that can no longer be contained in over-the-counter consumer antiseptic/antibacterial wash products.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Does Not Meet Monograph: product contains, triclosan, an ingredient that can no longer be contained in over-the-counter consumer antiseptic/antibacterial wash products.

Code information

All Lots

Distribution pattern

Nationwide in the USA.