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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 73678

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

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Event summary

Timeline bucket
January 29, 2016
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Valeant Pharmacueticals International

Dossier provenance

Source snapshots represented here

  • openFDA Device 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.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

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.

device · product 1 of 1

Orapharma (Onpharma) Onset Mixing Pen Rx only, Product/Part Number 1054-02. Manufactured for Onpharma Inc. Los Gratos, CA 95030 The Mixing Pen is used to dispense a solution from a standard 3 mL size cartridge into a second fluid container.

Z-1699-2016
Recall number
Z-1699-2016
Initiated
January 29, 2016
Classification
Class II
Status
Terminated
Quantity
7,716

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
It has been determined that the Onset Mixing Pen has an optimal use period of 18 months from start of use. However, the current labeling and IFU does not stipulate this time period.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling False and Misleading

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

It has been determined that the Onset Mixing Pen has an optimal use period of 18 months from start of use. However, the current labeling and IFU does not stipulate this time period.

Code information

Dosing Mechanism Lot Entry 14090 14452 17133 18004 18403 18583 18757

Distribution pattern

Nationwide Distribution