Cortaid Intensive Therapy Cooling Spray recalled over manufacturing violations

Recall date

August 24, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Valeant Pharmaceuticals North America LLC recalls Cortaid Intensive Therapy Cooling Spray (1% hydrocortisone), 2 FL OZ (59 mL) spray bottle, OTC, Distributed by: Valeant…

Recall number

D-0084-2019

FDA classification

Class II

Brand / firm

Valeant Pharmaceuticals North America LLC

Sold / distributed

Product was distributed throughout the United States

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What 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