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Recall Observatory FDA recall evidence

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

August 24, 2018

Class II

Product summary

Firm
Valeant Pharmaceuticals North America LLC
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

    reason.manufacturing_process_control · v1.0.0

    CGMP deviations
  • Microbial contamination

    reason.microbial_contamination · v1.0.0

    microbial contamination