Class III โ€” Low Risk

Low risk โ€” use of or exposure to this product is not likely to cause adverse health consequences.

Novacort Gel Sample Packets (2% hydrocortisone acetate Recalled by Novum Pharma, LLC Due to Subpotent Drug: Out of specification result for pramoxine...

Date: December 7, 2016
Company: Novum Pharma, LLC
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Novum Pharma, LLC directly.

Affected Products

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

Quantity: 6,763 1 gram sample packets

Why Was This Recalled?

Subpotent Drug: Out of specification result for pramoxine hydrochloride

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Novum Pharma, LLC

Novum Pharma, LLC has 1 total recall tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report