FDA recall D-0433-2017

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

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2016-12-07

Report date

2017-01-25

Termination date

2019-04-08

Voluntary/Mandated

Voluntary: Firm initiated

Location

Chicago, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0433-2017