# FDA recall D-0454-2023

> **Akron Pharma, Inc.** · Class III · drug recall initiated 2023-02-17.

## Product

DIBUCAINE 1% HEMORRHOIDAL OINTMENT, 1 oz. (28 gm), Manufactured for: Akron Pharma Inc. Fairfield NJ 07004, NDC 71399-2829-1

## Reason for recall

Labeling: Incorrect or Missing Lot and/or Exp Date

## Distribution

Nationwide within the United States

## Key facts

- **Recall number:** D-0454-2023
- **Recalling firm:** Akron Pharma, Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2023-02-17
- **Report date:** 2023-03-15
- **Termination date:** 2024-09-09

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Fairfield, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0454-2023

## Citation

> AI Analytics. FDA recall D-0454-2023. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/D-0454-2023. Source: US FDA. Licensed CC0.

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