Exact FDA event identifier

Event 73174

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

Event summary

Timeline bucket: January 27, 2016
Product types: Drug
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Bonita Pharmaceuticals, 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

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

Menthocin Patch with Lidocaine-Strong (Menthol 5%, Capsaicin 0.0375%, Methyl Salicylate 20%, Lidocaine 0.5%), packaged in a box 15 patches, RX Only, Manufactured for Bonita Pharmaceuticals LLC 6380 Commerce Drive Westland, MI 48185-9120, USA NDC 53598-0012-15

D-0665-2016

Recall number: D-0665-2016
Initiated: January 27, 2016
Classification: Class II
Status: Terminated
Recalling firm: Bonita Pharmaceuticals, LLC
Quantity: 3,308 boxes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Marketed without an approved NDA/ANDA

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Marketed without an approved NDA/ANDA

Code information

Lot#: 20150326, Exp 03/2018

Distribution pattern

Nationwide