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.
Reported: June 22, 2016 Initiated: May 23, 2016 #D-1032-2016
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.
Details
- Recalling Firm
- Valeant Pharmaceuticals North America LLC
- Units Affected
- 3827 bottles
- Distribution
- Nationwide
- Location
- Bridgewater, NJ
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Valeant Pharmaceuticals North America LLC. Units affected: 3827 bottles.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on June 22, 2016. Severity: Low. Recall number: D-1032-2016.
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