D-0084-2019 Class II Terminated
FDA drug recall D-0084-2019 was initiated by Valeant Pharmaceuticals North America LLC on August 24, 2018 and is designated Class II. 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'… The recall status is terminated (terminated March 6, 2020). Affected quantity: 18,408 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- October 31, 2018
- Initiation Date
- August 24, 2018
- Termination Date
- March 6, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 18,408 bottles
Product Description
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.
Distribution Pattern
Product was distributed throughout the United States
Code Information
Lot #: 171205E, 171951E, Exp 5/19; 173365K, Exp 10/19