Reported Jun 22, 2016 · Terminated
Lodrane D (Brompheniramine maleate 4 mg and Pseudoephedrine HCl 60 mg) Capsules, 60-count bottles, Distributed by:…
Valeant Pharmaceuticals North America LLC
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Valeant Pharmaceuticals North America LLC · 400 Somerset Corporate Blvd · Bridgewater, NJ · 08807-2867
Is this the product you have?
- Lodrane D (Brompheniramine maleate 4 mg and Pseudoephedrine HCl 60 mg) Capsules, 60-count bottles
- Distributed byValeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807, UPC 0 00950 86006 8
- Lot codes and dates
Lot #'s P0230-022RP0230-023RExp 06/17
- Amount recalled
- 3827 bottles
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
Why it was 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.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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