# FDA recall D-0433-2017

> **Novum Pharma, LLC** · Class III · drug recall initiated 2016-12-07.

## 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

- **Recall number:** D-0433-2017
- **Recalling firm:** Novum Pharma, LLC
- **Classification:** Class III
- **Product type:** drug
- **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

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

## Citation

> AI Analytics. FDA recall D-0433-2017. Retrieved 2026-06-01 from https://api.ai-analytics.org/recall/D-0433-2017. Source: US FDA. Licensed CC0.

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