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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 67457

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

Open FDA event record

Event summary

Timeline bucket
February 07, 2014
Product types
Drug
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Actavis

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

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

Gelnique (oxybutynin chloride) Gel 10%, 100 mg in 1 g sachet, for topical use only. Physician sample in clamshell container with seven heat-sealed sachets. Rx Only. Watson Pharmaceuticals Inc, Corona, CA, 92890. NDC: 52544-084-77.

D-1088-2014
Recall number
D-1088-2014
Initiated
February 07, 2014
Classification
Class III
Status
Terminated
Recalling firm
Actavis
Quantity
38,227 Clamshells

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Subpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Subpotent Drug: Drug potency was compromised during shipment.

Code information

Lot #: 514656; Expiry: 03/14

Distribution pattern

Distributed nationwide to physicians as samples. No military/ govt/ VA or foreign consignees.