🔍 RecallPedia

Novacort Gel Sample Packets (2% hydrocortisone acetate, 1% pramoxine HCl), 10-count Carton of 1.0 g sample packets), NDC 69646-704-38 (10 ct. Carton of 1gm samples) / NDC 69646-704-01 (Individual 1gm Samples within Carton), Rx Only, Novum Pharma LLC, Chicago, IL 60654

Class I - Dangerous
💊 Drugs Recalled: December 7, 2016 Novum Pharma Prescription Drugs Nationwide

What Should You Do?

  1. Check if you have this product:
    Lot: 8249 - Exp. Date: 03/18 Lot: 8250 - Exp. Date: 06/18
  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:
Novum Pharma, LLC
Reason for Recall:
Subpotent Drug: Out of specification result for pramoxine hydrochloride
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Novacort Gel Sample Packets (2% hydrocortisone acetate, 1% pramoxine HCl), 10-count Carton of 1.0 g sample packets), NDC 69646-704-38 (10 ct. Carton of 1gm samples) / NDC 69646-704-01 (Individual 1gm Samples within Carton), Rx Only, Novum Pharma LLC, Chicago, IL 60654

Product Codes/Lot Numbers:

Lot: 8249 - Exp. Date: 03/18 Lot: 8250 - Exp. Date: 06/18

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-0433-2017