PlainRecalls
FDA Drug Moderate 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

Reported: October 31, 2018 Initiated: August 24, 2018 #D-0085-2019

Product Description

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

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
119,594 tubes
Distribution
Product was distributed throughout the United States
Location
Bridgewater, NJ

Frequently Asked Questions

What product was recalled?
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. Recalled by Valeant Pharmaceuticals North America LLC. Units affected: 119,594 tubes.
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-0085-2019.