Valeant Recalls Mislabelled Lodrane D Capsules Due to Incorrect Ingredient Labeling
Valeant Pharmaceuticals is recalling 3,827 bottles of Lodrane D capsules because the outer cartons were mislabeled with the wrong active ingredient.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class III, which indicates a low risk of adverse health consequences. The hazard is a minor labeling error where the outer carton lists the wrong active ingredient, but the bottles themselves are correctly labeled.
Plain-English summary
Valeant Pharmaceuticals North America LLC is recalling 3,827 bottles of Lodrane D (Brompheniramine maleate 4 mg and Pseudoephedrine HCl 60 mg) Capsules. The recall involves 60-count bottles distributed nationwide. The specific lots affected are P0230-022R and P0230-023R, with an expiration date of 06/17.
The reason for the recall is a labeling error. While the bottles themselves were correctly labeled, they were packaged in cartons that were mislabeled. The cartons incorrectly listed phenylephrine as the active ingredient instead of pseudoephedrine on the carton face and top.
Consumers who have purchased these specific bottles should check the lot numbers and expiration dates on their packaging. If the product matches the recalled description, consumers should stop using it and contact Valeant Pharmaceuticals or their healthcare provider for further instructions.
The recalled product
- 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.
- Manufacturer
- Valeant Pharmaceuticals North America LLC
- Category
- Drug — Cold and Allergy
- Hazard
- Affected units
- 3,827
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot #'s P0230-022R
- P0230-023R
- Exp 06/17
Distribution
Distributed nationwide across the United States.
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