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.
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.
Lot numbers, UPCs & expiration codes
Lot #'s P0230-022R, P0230-023R, Exp 06/17
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1032-2016
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- May 23, 2016
- FDA report date
- Jun 22, 2016
- Quantity
- 3827 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Valeant Pharmaceuticals North America LLC
Original FDA data
Every field from FDA enforcement report D-1032-2016, exactly as published.
Show all FDA fields
- City
- Bridgewater
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 74223
- Address
- 400 Somerset Corporate Blvd
- Code information
- Lot #'s P0230-022R, P0230-023R, Exp 06/17
- Postal code
- 08807-2867
- Report date
- Jun 22, 2016
- Product type
- Drugs
- Recall number
- D-1032-2016
- Classification
- Class III
- Recalling firm
- Valeant Pharmaceuticals North America LLC
- Product quantity
- 3827 bottles
- Termination date
- Sep 12, 2017
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Nationwide
- Recall initiation date
- May 23, 2016
- Initial firm notification
- Letter
- Center classification date
- Jun 15, 2016