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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 74223

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

Open FDA event record

Event summary

Timeline bucket
May 23, 2016
Product types
Drug
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Valeant Pharmaceuticals North America 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

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

Lodrane D (Brompheniramine maleate 4 mg and Pseudoephedrine HCl 60 mg) Capsules, 60-count bottles, Distributed by: Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807, UPC 0 00950 86006 8.

D-1032-2016
Recall number
D-1032-2016
Initiated
May 23, 2016
Classification
Class III
Status
Terminated
Quantity
3827 bottles

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
mislabeled

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Labeling: Not Elsewhere Classified: correctly labeled bottles were packaged in cartons that were mislabeled with an incorrect active ingredient, phenylephrine rather than pseudoephedrine, on the carton face and carton top.

Code information

Lot #'s P0230-022R, P0230-023R, Exp 06/17

Distribution pattern

Nationwide