D-0433-2017 Class III Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- January 25, 2017
- Initiation Date
- December 7, 2016
- Termination Date
- April 8, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6,763 1 gram sample packets
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
Distribution Pattern
Nationwide
Code Information
Lot: 8249 - Exp. Date: 03/18 Lot: 8250 - Exp. Date: 06/18