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

FDA recall notice · announced October 31, 2018 · Valeant Pharmaceuticals

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

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.

Notes

Distribution: Product was distributed throughout the United States
Lot/code information: Lot #: 171205E, 171951E, Exp 5/19; 173365K, Exp 10/19
Quantity: 18,408 bottles
Status: Terminated
Products in this recall event:
- 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 (D-0085-2019)
- Cortaid 12-Hour Advanced Anti-itch Cream (1% hydrocortisone), NET WT 1.5 oz. (42 g) tube, OTC, Distributed by: Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807, UPC code 301875519155 (D-0086-2019)
- 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 (D-0084-2019)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.