Home / Recalls / Valeant Pharmaceuticals North America LLC / D-0084-2019

D-0084-2019 Class II Terminated

Recalled by Valeant Pharmaceuticals North America LLC — Bridgewater, NJ

Recall Details

Product Type
Drugs
Report Date
October 31, 2018
Initiation Date
August 24, 2018
Termination Date
March 6, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
18,408 bottles

Product Description

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

Reason for Recall

CGMP deviations: Notice received from supplier of a voluntary recall of all their nasal products and baby oral gels due to the possibility of microbial contamination. No positive results for the firm's products. were obtained. After the firm review, cGMP deviations ere evident.

Distribution Pattern

Product was distributed throughout the United States

Code Information

Lot #: 171205E, 171951E, Exp 5/19; 173365K, Exp 10/19

Other recalls by Valeant Pharmaceuticals North America LLC

  • D-0487-2019 Class III — Cardizem CD (diltiazem HCl) capsules, 120 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-0490-2019 Class III — Cardizem CD (diltiazem HCl) capsules, 300 mg, packaged in a) 30-count bottles (N (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-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-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)