Class III
Terminated
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.
- Recall Initiated
- May 23, 2016
- Posted
- June 22, 2016
- Recall Number
- D-1032-2016
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 3827 bottles
- Firm Location
- Bridgewater, NJ, United States
Reason for Recall
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.
Distribution
Nationwide
Lot / Code Info
Lot #'s P0230-022R, P0230-023R, Exp 06/17
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