Food, drugs, devices › Valeant Pharmaceuticals North America LLC
Drug recall: Cortaid Intensive Therapy Cooling Spray (1% hydrocortisone), 2 FL OZ (59 mL) spray bottle, OTC, Distributed by: Valeant
Valeant Pharmaceuticals North America LLC (Bridgewater, NJ) initiated this drug recall on 24 Aug 2018; FDA lists 3 product records under event 81004, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 60% of the 367 drug enforcement events initiated in 2018 carry the same class.
Status: Terminated, terminated 6 Mar 2020. Initiation: voluntary: firm initiated. Valeant Pharmaceuticals North America LLC has 14 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Valeant Pharmaceuticals North America LLC, Bridgewater, NJ.
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
"Product was distributed throughout the United States"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-0084-2019 | 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 | 18,408 bottles | Class II | Terminated | 31 Oct 2018 |
| D-0085-2019 | 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 | 119,594 tubes | Class II | Terminated | 31 Oct 2018 |
| D-0086-2019 | 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 | 5,016 tubes | Class II | Terminated | 31 Oct 2018 |
Context
Other enforcement events for Valeant Pharmaceuticals North America LLC
All 14 events for Valeant Pharmaceuticals North America LLC
Questions and answers
Why was this drug recalled?
FDA's record gives the reason for recall as: "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."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Product was distributed throughout the United States"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 6 Mar 2020. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.