Medications & Supplements/Topical Products

Valeant Pharmaceuticals North America LLC: Various Cortaid Hydrocortisone Products Recalled for Microbial Risk

Agency Publication Date: October 22, 2018

Summary

Valeant Pharmaceuticals North America LLC is recalling approximately 143,018 units of Cortaid Intensive Therapy Cooling Spray, Maximum Strength Cream, and 12-Hour Advanced Anti-itch Cream (1% hydrocortisone). This recall was initiated following a notice from a supplier regarding potential microbial contamination and identified deviations from good manufacturing practices (cGMP). Consumers should stop using these products immediately and contact a healthcare professional if they have experienced any adverse effects.

Risk

Although no positive contamination results were obtained for these specific products, they were manufactured under conditions that did not meet safety standards, posing a risk of microbial contamination that could lead to infections or skin irritation.

What You Should Do

Check your medicine cabinet for Cortaid Intensive Therapy Cooling Spray (2 FL OZ) with UPC 301875518028 and Lot numbers 171205E, 171951E (Exp 5/19), or 173365K (Exp 10/19).
Check for Cortaid Maximum Strength Cream (1 OZ) with UPC 301875521011 and Lot numbers 170843B (Exp 2/19), 171484D (Exp 4/19), 171791E or 171848E (Exp 5/19), 172359J, 172360J, or 173184J (Exp 9/19), 173512P (Exp 12/19), 180180B (Exp 2/20), or 181098C (Exp 3/20).
Check for Cortaid 12-Hour Advanced Anti-itch Cream (1.5 oz) with UPC 301875519155 and Lot number 172185F (Exp 6/19).
If you identify an affected product, stop using it immediately to avoid potential exposure to microbial contaminants.
Contact your healthcare provider or pharmacist for guidance regarding use and return any unused product to the place of purchase for a refund.
Contact Valeant Pharmaceuticals North America LLC at their Bridgewater, NJ office for further instructions regarding this recall.
For additional questions or to report a reaction, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

Full Refund

Drug recall baseline refund and professional consultation

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Cortaid Intensive Therapy Cooling Spray (2 FL OZ)

Model:

Recall #: D-0084-2019

UPC Codes:

301875518028

Lot Numbers:

171205E (Exp 5/19)

171951E (Exp 5/19)

173365K (Exp 10/19)

Date Ranges: Expiration 5/19, Expiration 10/19

Product: Cortaid Maximum Strength Cream (1 OZ)

Model:

Recall #: D-0085-2019

UPC Codes:

301875521011

Lot Numbers:

170843B (Exp 2/19)

171484D (Exp 4/19)

171791E (Exp 5/19)

171848E (Exp 5/19)

172359J (Exp 9/19)

172360J (Exp 9/19)

173184J (Exp 9/19)

173512P (Exp 12/19)

180180B (Exp 2/20)

181098C (Exp 3/20)

Date Ranges: Expiration 2/19, Expiration 4/19, Expiration 5/19, Expiration 9/19, Expiration 12/19, Expiration 2/20, Expiration 3/20

Product: Cortaid 12-Hour Advanced Anti-itch Cream (1.5 oz)

Model:

Recall #: D-0086-2019

UPC Codes:

301875519155

Lot Numbers:

172185F (Exp 6/19)

Date Ranges: Expiration 6/19

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 81004

Status: Resolved

Manufacturer: Valeant Pharmaceuticals North America LLC

Sold By: Retailers nationwide

Manufactured In: United States

Units Affected: 3 products (18,408 bottles; 119,594 tubes; 5,016 tubes)

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Check your medicine cabinet for Cortaid Intensive Therapy Cooling Spray (2 FL OZ) with UPC 301875518028 and Lot numbers 171205E, 171951E (Exp 5/19), or 173365K (Exp 10/19).

Check for Cortaid Maximum Strength Cream (1 OZ) with UPC 301875521011 and Lot numbers 170843B (Exp 2/19), 171484D (Exp 4/19), 171791E or 171848E (Exp 5/19), 172359J, 172360J, or 173184J (Exp 9/19), 173512P (Exp 12/19), 180180B (Exp 2/20), or 181098C (Exp 3/20).

Check for Cortaid 12-Hour Advanced Anti-itch Cream (1.5 oz) with UPC 301875519155 and Lot number 172185F (Exp 6/19).

If you identify an affected product, stop using it immediately to avoid potential exposure to microbial contaminants.

Contact your healthcare provider or pharmacist for guidance regarding use and return any unused product to the place of purchase for a refund.

Contact Valeant Pharmaceuticals North America LLC at their Bridgewater, NJ office for further instructions regarding this recall.

For additional questions or to report a reaction, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Affected Products

Product: Cortaid Intensive Therapy Cooling Spray (2 FL OZ)

Model:

Recall #: D-0084-2019

UPC Codes:

301875518028

Lot Numbers:

171205E (Exp 5/19)

171951E (Exp 5/19)

173365K (Exp 10/19)

Date Ranges: Expiration 5/19, Expiration 10/19

Product: Cortaid Maximum Strength Cream (1 OZ)

Model:

Recall #: D-0085-2019

UPC Codes:

301875521011

Lot Numbers:

170843B (Exp 2/19)

171484D (Exp 4/19)

171791E (Exp 5/19)

171848E (Exp 5/19)

172359J (Exp 9/19)

172360J (Exp 9/19)

173184J (Exp 9/19)

173512P (Exp 12/19)

180180B (Exp 2/20)

181098C (Exp 3/20)

Date Ranges: Expiration 2/19, Expiration 4/19, Expiration 5/19, Expiration 9/19, Expiration 12/19, Expiration 2/20, Expiration 3/20

Product: Cortaid 12-Hour Advanced Anti-itch Cream (1.5 oz)

Model:

Recall #: D-0086-2019

UPC Codes:

301875519155

Lot Numbers:

172185F (Exp 6/19)

Date Ranges: Expiration 6/19