Exact FDA event identifier

Event 90869

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

Event summary

Timeline bucket: September 12, 2022
Product types: Drug
Classifications: Class II
Statuses: Completed
Recalling firm wording: Direct Rx

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

Triamcinolone Acetonide cream, 0.1%, 80 g tube, Rx only, Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534, Dist. By Perrigo, Allegan, MI 49010, NDC 72189-330-80.

D-1535-2022

Recall number: D-1535-2022
Initiated: September 12, 2022
Classification: Class II
Status: Completed
Recalling firm: Direct Rx
Quantity: 20 tubes

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: Product complaints reporting the product to have a gritty texture and lack of effectiveness.

Code information

Lot: 12JY2216, Exp. 2/29/24

Distribution pattern

Physicians and Medical Facilities in GA and ID