FDA Drug recall D-0433-2017
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
- FDA Drug
- Class III
- terminated
- Published 2017-01-25
On 2017-01-25 the FDA classified a Class III recall of 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 by Novum Pharma, citing subpotent Drug: Out of specification result for pramoxine hydrochloride.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0433-2017 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2016-12-07 |
| Published | 2017-01-25 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Novum Pharma |
| Distribution | US |
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
Subpotent Drug: Out of specification result for pramoxine hydrochloride
Identifiers
| code_info | Lot: 8249 - Exp. Date: 03/18 Lot: 8250 - Exp. Date: 06/18 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0433-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.