The Recall Desk

FDA (Drugs) recall action 81004

Valeant Pharmaceuticals North America LLC recalled 3 products on 2018-10-31

The FDA (Drugs) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.

Products
3
Announced
2018-10-31
Critical
0
Units
143,018

Why these products were 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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–3 of 3

  • ModerateFDA (Drugs)··2018-10-31

    Valeant Recalls Cortaid Intensive Therapy Cooling Spray Due to cGMP Deviations

    Valeant Pharmaceuticals is recalling specific lots of Cortaid Intensive Therapy Cooling Spray due to cGMP deviations identified after a supplier recall for microbial contamination.

    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
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2018-10-31

    Valeant Recalls Cortaid Maximum Strength Cream Due to cGMP Deviations

    Valeant Pharmaceuticals is recalling specific lots of Cortaid Maximum Strength Cream due to current Good Manufacturing Practice (cGMP) deviations identified during a supplier review.

    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
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2018-10-31

    Valeant Recalls Cortaid 12-Hour Anti-itch Cream Due to cGMP Deviations

    Valeant Pharmaceuticals is recalling 5,016 tubes of Cortaid 12-Hour Advanced Anti-itch Cream due to current Good Manufacturing Practice (cGMP) deviations identified during a supplier review.

    Product
    Cortaid 12-Hour Advanced Anti-itch Cream (1% hydrocortisone), NET WT 1.5 oz. (42 g) tube, OTC, Distributed by: Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807, UPC code 301875519155
    Category
    Distribution
    0 states