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Recall Observatory FDA recall evidence

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

May 23, 2016

Class III

Product summary

Firm
Valeant Pharmaceuticals North America LLC
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

    reason.labeling_packaging · v1.0.0

    mislabeled