Valeant Pharmaceuticals North America LLC

FDA Regulatory Profile

Summary

Total Recalls
25
510(k) Clearances
0
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
D-0491-2019Class IIIDiltiazem HCl CD capsules, 360 mg, 90-count bottles, Rx Only, Manufactured for: Oceanside PharmaceutJanuary 30, 2019
D-0489-2019Class IIICardizem CD (diltiazem HCl) capsules, 240 mg, packaged in a) 30-count bottles (NDC 0187-0797-30); anJanuary 30, 2019
D-0487-2019Class IIICardizem CD (diltiazem HCl) capsules, 120 mg, packaged in a) 30-count bottles (NDC 0187-0795-30); anJanuary 30, 2019
D-0488-2019Class IIICardizem CD (diltiazem HCl) capsules, 180 mg, packaged in a) 30-count bottles (NDC 0187-0796-30); anJanuary 30, 2019
D-0490-2019Class IIICardizem CD (diltiazem HCl) capsules, 300 mg, packaged in a) 30-count bottles (NDC 0187-0798-30); anJanuary 30, 2019
D-0086-2019Class IICortaid 12-Hour Advanced Anti-itch Cream (1% hydrocortisone), NET WT 1.5 oz. (42 g) tube, OTC, DistrAugust 24, 2018
D-0085-2019Class IICortaid Maximum Strength Cream (1% hydrocortisone), 1 OZ (28 g) tube, OTC, Distributed by: Valeant PAugust 24, 2018
D-0084-2019Class IICortaid Intensive Therapy Cooling Spray (1% hydrocortisone), 2 FL OZ (59 mL) spray bottle, OTC, DistAugust 24, 2018
D-1041-2018Class IIIDiazepam Rectal Gel, 2.5 mg, TWIN PACK that Contains two pre-filled, unit-dose, rectal delivery systJuly 10, 2018
D-0998-2017Class IIIObagi-C Rx System C-Therapy Night Cream, Net wt. 2 oz. (57g) bottle, Rx only, Distributed by OMP, InJune 28, 2017
D-0673-2017Class IIICLENZIderm M.D. Acne Treatment System, kit has 3 bottles a) Therapeutic Lotion (benzoyl peroxide 5% March 20, 2017
D-0672-2017Class IIICLENZIderm M.D. Pore Therapy Salicylic Acid 2% Acne Treatment 5 fl. oz. (148 mL), Valeant PharmaceutMarch 20, 2017
D-1059-2016Class IIISECONAL SODIUM (secobarbital sodium) Capsules, USP, 100 mg, 100 Ct. Bottles, Rx Only. Distributed byJune 10, 2016
D-1032-2016Class IIILodrane D (Brompheniramine maleate 4 mg and Pseudoephedrine HCl 60 mg) Capsules, 60-count bottles, DMay 23, 2016
Z-0371-2016Class IIValeant Pharmaceuticals North America Model No. Spag-2 Small Particle Size Aerosol Generator SPAG-2September 14, 2015
D-0163-2016Class IIFenoglide (fenofibrate) tablets, 120 mg Tablets, 90 Ct Bottle, Rx Only. Distributed by: Santarus, InSeptember 4, 2015
D-1034-2016Class IIILibrax (5 mg chlordiazepoxide HCl and 2.5 mg clidinium bromide) capsules, 100-count bottle, Rx Only,April 18, 2015
D-1035-2016Class IIIChlordiazepoxide HCl/Clidinium Bromide capsules, 5 /2.5 mg, 100-count bottle, Rx Only, Manufactured April 18, 2015
D-1116-2015Class IINifedipine Extended-Release Tablets, USP, 90 mg, 100 Tablet Bottles, Rx Only. Manufactured for: TevaApril 17, 2015
D-0379-2015Class IIVirazole (Ribavirin for Inhalation Solution, USP), Sterile Lyophilized For Administration by AerosolDecember 31, 2014