PlainRecalls
FDA Drug Moderate 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

Reported: October 31, 2018 Initiated: August 24, 2018 #D-0084-2019

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.

Details

Units Affected
18,408 bottles
Distribution
Product was distributed throughout the United States
Location
Bridgewater, NJ

Frequently Asked Questions

What product was recalled?
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. Recalled by Valeant Pharmaceuticals North America LLC. Units affected: 18,408 bottles.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Drug on October 31, 2018. Severity: Moderate. Recall number: D-0084-2019.