Recalls / Class III
Class IIID-1032-2016
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.
- Affected lot / code info
- Lot #'s P0230-022R, P0230-023R, Exp 06/17
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.
Recalling firm
- Firm
- Valeant Pharmaceuticals North America LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 400 Somerset Corporate Blvd, Bridgewater, New Jersey 08807-2867
Distribution
- Quantity
- 3827 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2016-05-23
- FDA classified
- 2016-06-15
- Posted by FDA
- 2016-06-22
- Terminated
- 2017-09-12
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1032-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.