Valeant Pharmaceuticals North America LLC

FDA Drug Class III Terminated

Cardizem CD (diltiazem HCl) capsules, 120 mg, packaged in a) 30-count bottles (NDC 0187-0795-30); and b) 90-count bottles (NDC 0187-0795-42), Rx Only, Manufactured for: Valeant Pharmaceuticals North A

January 30, 2019 Valeant Pharmaceuticals North America LLC 1023 bottles units

FDA Drug Class III Terminated

Cardizem CD (diltiazem HCl) capsules, 240 mg, packaged in a) 30-count bottles (NDC 0187-0797-30); and b) 90-count bottles (NDC 0187-0797-42), Rx Only, Manufactured for: Valeant Pharmaceuticals North A

January 30, 2019 Valeant Pharmaceuticals North America LLC 390 bottles units

FDA Drug Class III Terminated

Cardizem CD (diltiazem HCl) capsules, 180 mg, packaged in a) 30-count bottles (NDC 0187-0796-30); and b) 90-count bottles (NDC 0187-0796-42), Rx Only, Manufactured for: Valeant Pharmaceuticals North A

January 30, 2019 Valeant Pharmaceuticals North America LLC 206 bottles units

FDA Drug Class III Terminated

Cardizem CD (diltiazem HCl) capsules, 300 mg, packaged in a) 30-count bottles (NDC 0187-0798-30); and b) 90-count bottles (NDC 0187-0798-42), Rx Only, Manufactured for: Valeant Pharmaceuticals North A

January 30, 2019 Valeant Pharmaceuticals North America LLC 22 bottles units

FDA Drug Class III Terminated

Diltiazem HCl CD capsules, 360 mg, 90-count bottles, Rx Only, Manufactured for: Oceanside Pharmaceuticals, a division of Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807 USA; By: Valea

January 30, 2019 Valeant Pharmaceuticals North America LLC 23,884 bottles units

FDA Drug Class II Terminated

Cortaid Intensive Therapy Cooling Spray (1% hydrocortisone), 2 FL OZ (59 mL) spray bottle, OTC, Distributed by: Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807, UPC code 301875518028

August 24, 2018 Valeant Pharmaceuticals North America LLC 18,408 bottles units

FDA Drug Class II Terminated

Cortaid 12-Hour Advanced Anti-itch Cream (1% hydrocortisone), NET WT 1.5 oz. (42 g) tube, OTC, Distributed by: Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807, UPC code 301875519155

August 24, 2018 Valeant Pharmaceuticals North America LLC 5,016 tubes units

FDA Drug Class II Terminated

Cortaid Maximum Strength Cream (1% hydrocortisone), 1 OZ (28 g) tube, OTC, Distributed by: Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807, UPC code 301875521011

August 24, 2018 Valeant Pharmaceuticals North America LLC 119,594 tubes units

FDA Drug Class III Terminated

Diazepam Rectal Gel, 2.5 mg, TWIN PACK that Contains two pre-filled, unit-dose, rectal delivery systems with lubricating jelly and instructions for use per carton, Rx only, Manufactured for: Oceanside

July 10, 2018 Valeant Pharmaceuticals North America LLC 306 cartons units

FDA Drug Class III Terminated

Obagi-C Rx System C-Therapy Night Cream, Net wt. 2 oz. (57g) bottle, Rx only, Distributed by OMP, Inc., Long Beach, CA Made in USA, NDC 62032-222-02

June 28, 2017 Valeant Pharmaceuticals North America LLC 844 bottles units

FDA Drug Class III Terminated

CLENZIderm M.D. Pore Therapy Salicylic Acid 2% Acne Treatment 5 fl. oz. (148 mL), Valeant Pharmaceuticals North America LLC Distributed by OMP, Inc Long Beach, CA 90806 Made in USA. Product SKU 301876

March 20, 2017 Valeant Pharmaceuticals North America LLC 38,767 units units

FDA Drug Class III Terminated

CLENZIderm M.D. Acne Treatment System, kit has 3 bottles a) Therapeutic Lotion (benzoyl peroxide 5% Acne Treatment) 47mL bottle, b) Daily Care Foaming Cleanser (Salicylic Acid 2% Acne Treatment) 118 m

March 20, 2017 Valeant Pharmaceuticals North America LLC 5,647 units units

FDA Drug Class III Terminated

SECONAL SODIUM (secobarbital sodium) Capsules, USP, 100 mg, 100 Ct. Bottles, Rx Only. Distributed by: Valeant Pharmaceuticals North America, LLC, Bridgewater, NJ 08807. NDC: 0187-4220-10.

June 10, 2016 Valeant Pharmaceuticals North America LLC 958 Bottles units

FDA Drug Class III Terminated

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

May 23, 2016 Valeant Pharmaceuticals North America LLC 3827 bottles units

FDA Drug Class II Terminated

Fenoglide (fenofibrate) tablets, 120 mg Tablets, 90 Ct Bottle, Rx Only. Distributed by: Santarus, Inc. San Diego, CA 92130. NDC: 68012-495-90.

September 4, 2015 Valeant Pharmaceuticals North America LLC 3341 Bottles units

FDA Drug Class III Terminated

Chlordiazepoxide HCl/Clidinium Bromide capsules, 5 /2.5 mg, 100-count bottle, Rx Only, Manufactured in Canada by: Valeant Pharmaceuticals International, Inc., Steinbach, MB R5G 1Z7 Canada; Manufactur

April 18, 2015 Valeant Pharmaceuticals North America LLC 564,454 bottles units

FDA Drug Class III Terminated

Librax (5 mg chlordiazepoxide HCl and 2.5 mg clidinium bromide) capsules, 100-count bottle, Rx Only, Manufactured in Canada by: Valeant Pharmaceuticals International, Inc., Steinbach, MB R5G 1Z7 Canad

April 18, 2015 Valeant Pharmaceuticals North America LLC 6,321 bottles units

FDA Drug Class II Terminated

Nifedipine Extended-Release Tablets, USP, 90 mg, 100 Tablet Bottles, Rx Only. Manufactured for: Teva Pharmaceuticals USA Sailorsville, PA 13960. Manufactured in Canada By: Valeant Pharmaceuticals Inte

April 17, 2015 Valeant Pharmaceuticals North America LLC 93,237 Bottles units

FDA Drug Class II Terminated

Virazole (Ribavirin for Inhalation Solution, USP), Sterile Lyophilized For Administration by Aerosol Inhalation Only, Rx only, Contents: Four 6 g vials, 100 mL, Distributed by: Valeant Pharmaceutical

December 31, 2014 Valeant Pharmaceuticals North America LLC 2,428 vials units

FDA Drug Class III Terminated

APLENZIN¿ (bupropion hydrobromide), extended-release tablets, 174 mg, 7-count HDPE bottle, Rx Only, Manufactured by Valeant Pharmaceuticals International, Inc. Steinbach MB, Canada R5G 1Z7, NDC 0024-5

June 5, 2014 Valeant Pharmaceuticals North America LLC 20,499 HDPE bottles units

FDA Drug Class III Terminated

APLENZIN¿ (bupropion hydrobromide), extended-release tablets, 348 mg, a) 7-count HDPE bottle (NDC 0024-5811-07), b) 30-count HDPE bottle (NDC 0024-5811-30), Rx Only, Manufactured by Valeant Pharmaceut

June 5, 2014 Valeant Pharmaceuticals North America LLC 23,057 HDPE bottles units

FDA Drug Class III Terminated

APLENZIN¿ (bupropion hydrobromide), extended-release tablets, 522 mg, a) 7-count HDPE bottle (NDC 0024-5812-07), b) 30-count HDPE bottle (NDC 0024-5812-30), Rx Only, Manufactured by Valeant Pharmaceut

June 5, 2014 Valeant Pharmaceuticals North America LLC 55,650 HDPE bottles units

FDA Drug Class III Terminated

Vaseretic (enalapril maleate/hydrochlorothiazide) 10/25 mg Tablets, NDC 0187-0146-01, 100 ct. bottles manufactured at Valeant Pharmaceuticals International, Inc., Steinbach, MD R5G 1Z7 Canada

May 21, 2014 Valeant Pharmaceuticals North America LLC 205,853 bottles units

FDA Drug Class III Terminated

Vasotec (enalapril maleate) tablets, RX only, Manufactured by Valeant Pharmaceuticals International, Inc., Steinbach, MD R5G 1Z7 Canada 2.5 mg 90 ct - NDC 0187-0140-90 5 mg 30 ct - NDC 0187-0

May 21, 2014 Valeant Pharmaceuticals North America LLC 205,853 bottles units