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
Reason for recall: Subpotent Drug: Out of specification result for pramoxine hydrochloride
Recall initiated: 20161207
Status: Terminated
Classification: Class III
Recall type: Voluntary: Firm initiated