Lodrane D Capsules recalled over labeling errors

Recall date

May 23, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Valeant Pharmaceuticals North America LLC recalls Lodrane D (Brompheniramine maleate 4 mg and Pseudoephedrine HCl 60 mg) Capsules, 60-count bottles, Distributed by: Vale…

Recall number

D-1032-2016

FDA classification

Class III

Brand / firm

Valeant Pharmaceuticals North America LLC

Sold / distributed

Nationwide

Why it was recalled

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.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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.