🔍 RecallPedia

Mometasone Furoate Topical Solution, USP, 0.1%, (Lotion), a) 30 mL (NDC 0713-0701-85) and b) 60 mL (NDC 0713-0701-53), Rx Only, Distributed by: Cosette Pharmaceuticals, Inc., South Plainfield, NJ 07080

Class I - Dangerous
💊 Drugs Recalled: March 25, 2021 Cosette Pharmaceuticals Prescription Drugs Nationwide

What Should You Do?

  1. Check if you have this product:
    a) 30 mL: 1014611 and 1014612, exp 12/2022 b) 60 mL:1014593, 1014594 and 1014595, exp 10/2022
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Cosette Pharmaceuticals, Inc.
Reason for Recall:
CGMP Deviaitons
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

Mometasone Furoate Topical Solution, USP, 0.1%, (Lotion), a) 30 mL (NDC 0713-0701-85) and b) 60 mL (NDC 0713-0701-53), Rx Only, Distributed by: Cosette Pharmaceuticals, Inc., South Plainfield, NJ 07080

Product Codes/Lot Numbers:

a) 30 mL: 1014611 and 1014612, exp 12/2022 b) 60 mL:1014593, 1014594 and 1014595, exp 10/2022

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-0327-2021