Novum Pharma, LLC recalls Novacort Gel Sample Packets (2% hydrocortisone acetate, 1% pramoxine HCl), 10-count Carton of 1.0 g sample packets), ND…

Recall date

December 7, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0433-2017

FDA classification

Class III

Brand / firm

Novum Pharma, LLC

Sold / distributed

Nationwide

Why it was recalled

Subpotent Drug: Out of specification result for pramoxine hydrochloride

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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