FDA Drug Class III — Least Serious

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

Hazard

Subpotent Drug: Out of specification result for pramoxine hydrochloride

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
Brand
Novum Pharma, LLC
UPC
Lot: 8249 - Exp. Date: 03/18 Lot: 8250 - Exp. Date: 06/18

Units Affected

6,763 1 gram sample packets