FDA-Drug2017-01-25Class III
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
Novum Pharma, LLC
Hazard
Subpotent Drug: Out of specification result for pramoxine hydrochloride
Sold states
Nationwide
Affected count
6,763 1 gram sample packets
Manufactured in
Suite 670, 640 N. Lasalle Street, Chicago, IL, United States
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 Samples within Carton), Rx Only, Novum Pharma LLC, Chicago, IL 60654
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0433-2017Don't want to check this manually?
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