Novacort Gel Sample Packets (2% hydrocortisone acetate, 1% pramoxine HCl), 10-count Carton of 1.0...
FDA Recall #D-0433-2017 — Class III — December 7, 2016
Product 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
Reason for Recall
Subpotent Drug: Out of specification result for pramoxine hydrochloride
Recalling Firm
Novum Pharma, LLC — Chicago, IL
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
6,763 1 gram sample packets
Distribution
Nationwide
Code Information
Lot: 8249 - Exp. Date: 03/18 Lot: 8250 - Exp. Date: 06/18
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated