Recalls / Class II
Class IID-0084-2019
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
- Affected lot / code info
- Lot #: 171205E, 171951E, Exp 5/19; 173365K, Exp 10/19
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.
Recalling firm
- Firm
- Valeant Pharmaceuticals North America LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 400 Somerset Corporate Blvd, N/A, Bridgewater, New Jersey 08807-2867
Distribution
- Quantity
- 18,408 bottles
- Distribution pattern
- Product was distributed throughout the United States
Timeline
- Recall initiated
- 2018-08-24
- FDA classified
- 2018-10-22
- Posted by FDA
- 2018-10-31
- Terminated
- 2020-03-06
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0084-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.