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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 92868

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

Open FDA event record

Event summary

Timeline bucket
August 11, 2023
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
AVKARE LLC

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

Sodium Fluoride 1.1%, SODIUM FLUORIDE Prescription Dental Toothpaste, 5000 ppm Fluoride Plus Mild Cleaning System Spearmint NET WT. 1.8 OZ. (51g), Rx only, NDC 42291-741-51, Manufactured for: AvKARE Pulaski, TN 38478

D-1146-2023
Recall number
D-1146-2023
Initiated
August 11, 2023
Classification
Class II
Status
Terminated
Recalling firm
AVKARE LLC
Quantity
35,184 tubes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Cases of Sodium Fluoride 1.1% Prescription Dental Toothpaste may contain cartons labeled as Capsaicin Cream 0.025% but contain correctly labeled tubes of Sodium Fluoride 1.1% Prescription Dental Toothpaste

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Cases of Sodium Fluoride 1.1% Prescription Dental Toothpaste may contain cartons labeled as Capsaicin Cream 0.025% but contain correctly labeled tubes of Sodium Fluoride 1.1% Prescription Dental Toothpaste

Code information

Lot # P23025 Exp. 02/24/2025

Distribution pattern

Affected product was distributed to nineteen (19) consignees within the united states.

drug · product 2 of 2

Capsaicin Cream 0.025%, External Analgesic Cream, Penetrating Pain Relief, NET WT. 2.1 OZ. (60g) NDC 50268-195-60, Manufactured for: AvKARE, Pulaski, TN 38478

D-1147-2023
Recall number
D-1147-2023
Initiated
August 11, 2023
Classification
Class II
Status
Terminated
Recalling firm
AVKARE LLC
Quantity
35,184 cartons

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product mix-up: Cartons labeled Capsaicin Cream 0.025% may contain tubes of Sodium Fluoride 1.1% Prescription Dental Toothpaste

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Product mix-up: Cartons labeled Capsaicin Cream 0.025% may contain tubes of Sodium Fluoride 1.1% Prescription Dental Toothpaste

Code information

Lot # P22078; Exp. 11/30/2024

Distribution pattern

Affected product was distributed to nineteen (19) consignees within the united states.