FDAFDA · Food and drugs·Recall number D-1032-2016
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.
Published June 22, 2016 · Recall initiated: May 23, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's 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
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Valeant Pharmaceuticals North America LLC
- Distributor
- Nationwide
- Lot
- Lot #'s P0230-022R, P0230-023R, Exp 06/17
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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