Drug 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
D-0084-2019
Product summary
- Event
- Event 81004
- Status
- Terminated
- Classification
- Class II
- Quantity
- 18,408 bottles
- Official record key
drug-enforcement:D-0084-2019
Official wording
Reason: 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.
Code information: Lot #: 171205E, 171951E, Exp 5/19; 173365K, Exp 10/19
Distribution pattern: Product was distributed throughout the United States
Derived failure modes
-
Manufacturing or process control
CGMP deviations
-
Microbial contamination
microbial contamination