Home / Recalls / Valeant Pharmaceuticals North America LLC / D-1032-2016

D-1032-2016 Class III Terminated

Recalled by Valeant Pharmaceuticals North America LLC — Bridgewater, NJ

Recall Details

Product Type
Drugs
Report Date
June 22, 2016
Initiation Date
May 23, 2016
Termination Date
September 12, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
3827 bottles

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.

Distribution Pattern

Nationwide

Code Information

Lot #'s P0230-022R, P0230-023R, Exp 06/17

Other recalls by Valeant Pharmaceuticals North America LLC

  • D-0488-2019 Class III — Cardizem CD (diltiazem HCl) capsules, 180 mg, packaged in a) 30-count bottles (N (January 30, 2019)
  • D-0487-2019 Class III — Cardizem CD (diltiazem HCl) capsules, 120 mg, packaged in a) 30-count bottles (N (January 30, 2019)
  • D-0490-2019 Class III — Cardizem CD (diltiazem HCl) capsules, 300 mg, packaged in a) 30-count bottles (N (January 30, 2019)
  • D-0489-2019 Class III — Cardizem CD (diltiazem HCl) capsules, 240 mg, packaged in a) 30-count bottles (N (January 30, 2019)
  • D-0491-2019 Class III — Diltiazem HCl CD capsules, 360 mg, 90-count bottles, Rx Only, Manufactured for: (January 30, 2019)
  • D-0085-2019 Class II — Cortaid Maximum Strength Cream (1% hydrocortisone), 1 OZ (28 g) tube, OTC, Distr (August 24, 2018)
  • D-0086-2019 Class II — Cortaid 12-Hour Advanced Anti-itch Cream (1% hydrocortisone), NET WT 1.5 oz. (42 (August 24, 2018)
  • D-0084-2019 Class II — Cortaid Intensive Therapy Cooling Spray (1% hydrocortisone), 2 FL OZ (59 mL) spr (August 24, 2018)
  • D-1041-2018 Class III — Diazepam Rectal Gel, 2.5 mg, TWIN PACK that Contains two pre-filled, unit-dose, (July 10, 2018)
  • D-0998-2017 Class III — Obagi-C Rx System C-Therapy Night Cream, Net wt. 2 oz. (57g) bottle, Rx only, Di (June 28, 2017)