Home / Recalls / Valeant Pharmaceuticals North America LLC / D-0487-2019

D-0487-2019 Class III Terminated

Recalled by Valeant Pharmaceuticals North America LLC — Bridgewater, NJ

Recall Details

Product Type
Drugs
Report Date
February 20, 2019
Initiation Date
January 30, 2019
Termination Date
July 8, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1023 bottles

Product Description

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 America LLC, Bridgewater, NJ 08807 USA; By: Valeant Pharmaceuticals International, Inc., Steinbach, MB R5G 1Z7, Canada.

Reason for Recall

Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.

Distribution Pattern

Nationwide in the USA and Puerto Rico

Code Information

Lots: a) 18J023P, Exp 08/2020; b) 18J021P, Exp 08/2020

Other recalls by Valeant Pharmaceuticals North America LLC

  • 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-0488-2019 Class III — Cardizem CD (diltiazem HCl) capsules, 180 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-0085-2019 Class II — Cortaid Maximum Strength Cream (1% hydrocortisone), 1 OZ (28 g) tube, OTC, Distr (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-0086-2019 Class II — Cortaid 12-Hour Advanced Anti-itch Cream (1% hydrocortisone), NET WT 1.5 oz. (42 (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)
  • D-0672-2017 Class III — CLENZIderm M.D. Pore Therapy Salicylic Acid 2% Acne Treatment 5 fl. oz. (148 mL) (March 20, 2017)