Drug product
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
Product summary
- Event
- Event 74223
- Status
- Terminated
- Classification
- Class III
- Quantity
- 3827 bottles
- Official record key
drug-enforcement:D-1032-2016
Official wording
Reason: 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
Derived failure modes
-
Labeling or packaging
mislabeled