FDA-Drug2016-06-22Class III
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.
Valeant Pharmaceuticals North America LLC
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.
Sold states
Nationwide
Affected count
3827 bottles
Manufactured in
400 Somerset Corporate Blvd, Bridgewater, NJ, United States
Products
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 notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1032-2016Don't want to check this manually?
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