Drug product
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
Product summary
- Event
- Event 81004
- Status
- Terminated
- Classification
- Class II
- Quantity
- 119,594 tubes
- Official record key
drug-enforcement:D-0085-2019
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 #: 170843B, Exp 2/19; 171484D, Exp 4/19; 171791E, 171848E, Exp 5/19; 172359J, 172360J, 173184J, Exp 9/19; 173512P, Exp 12/19; 180180B, Exp 2/20; 181098C, Exp 3/20
Distribution pattern: Product was distributed throughout the United States
Derived failure modes
-
Manufacturing or process control
CGMP deviations
-
Microbial contamination
microbial contamination