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FDAMay 23, 2016drug

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.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Terminated

Brands named

valeant pharmaceuticals north americavaleantvaleant pharmaceuticals

UPCs

000950860068

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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