D-1032-2016 Class III Terminated
FDA drug recall D-1032-2016 was initiated by Valeant Pharmaceuticals North America LLC on May 23, 2016 and is designated Class III. 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 carto… The recall status is terminated (terminated September 12, 2017). Affected quantity: 3827 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- June 22, 2016
- Initiation Date
- May 23, 2016
- Termination Date
- September 12, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3827 bottles
Product Description
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.
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 Pattern
Nationwide
Code Information
Lot #'s P0230-022R, P0230-023R, Exp 06/17