Drug 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
D-0433-2017
Product summary
- Event
- Event 76233
- Status
- Terminated
- Classification
- Class III
- Quantity
- 6,763 1 gram sample packets
- Official record key
drug-enforcement:D-0433-2017
Official wording
Reason: Subpotent Drug: Out of specification result for pramoxine hydrochloride
Code information: Lot: 8249 - Exp. Date: 03/18 Lot: 8250 - Exp. Date: 06/18
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Subpotent