Exact FDA event identifier

Event 81603

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

Event summary

Timeline bucket: November 20, 2018
Product types: Drug
Classifications: Class II
Statuses: Terminated
Recalling firm wording: AVKARE 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

Germ Bloc Health Hand Sanitizer Foam (benzalkonium chloride 0.13%) 7.5fl.oz./222mL refill bags, AvKARE, Inc. Pulaski, TN 38478 www.avkare.com, NDC 5026835427, UPC 3 50268 35408

D-0285-2019

Recall number: D-0285-2019
Initiated: November 20, 2018
Classification: Class II
Status: Terminated
Recalling firm: AVKARE Inc.
Quantity: 1602 bags

App-derived interpretation

Microbial contamination reason.microbial_contamination · v1.0.0

Microbial Contamination

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Microbial Contamination of Non-Sterile Product: Presence of Pseudomonas aeruginosa in product

Code information

Lot #: 13417 Exp. 05/2020

Distribution pattern

WA only