Novacort Gel Sample Packets — Class III drug recall D-0433-2017
Terminated recall by Novum Pharma, LLC, reported 2017-01-25, distributed nationwide. Subpotent Drug: Out of specification result for pramoxine hydrochloride
| Recall number | D-0433-2017 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Novum Pharma, LLC, Chicago, IL, United States |
| Recall initiated | 2016-12-07 |
| Classified | 2017-01-17 |
| Reported by FDA | 2017-01-25 |
| Terminated | 2019-04-08 |
| Distributed | Nationwide (US) |
| Reason classes | potency, specification failure |
| NDC | 69646-0704-01, 69646-0704-38 |
| Lot numbers | 03/18, 06/18, 8249, 8250 |
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0433-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.