December 2016 FDA Recall Drug by Novum Pharma, Llc
D-0433-2017 - Subpotent Drug

This Class III drug recall was voluntarily initiated by Novum Pharma, Llc on December 7, 2016 for the product Drug. The FDA reported the reason for recall as subpotent drug. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0433-2017

Reason for Recall
Subpotent Drug: Out of specification result for pramoxine hydrochloride
Initiated
12-07-2016
Reported
01-25-2017
Quantity
6,763 1 gram sample packets

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
76233
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Novum Pharma, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-08-2019
Product Description About Product Description
Full technical description of the product.
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

Batch or Lot Expiration Information

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