DIBUCAINE 1% HEMORRHOIDAL OINTMENT — Class III drug recall D-0454-2023
Terminated recall by Akron Pharma, Inc., reported 2023-03-15, distributed nationwide. Labeling: Incorrect or Missing Lot and/or Exp Date
| Recall number | D-0454-2023 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Akron Pharma, Inc., Fairfield, NJ, United States |
| Recall initiated | 2023-02-17 |
| Classified | 2023-03-09 |
| Reported by FDA | 2023-03-15 |
| Terminated | 2024-09-09 |
| Distributed | Nationwide (US) |
| Quantity | 4,416 tubes |
| Reason classes | labeling |
| NDC | 71399-2829, 71399-2829-01, 71399-2829-02 |
| Lot numbers | 2206016 |
| Expiration dates | 2024-05 |
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
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-0454-2023. 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.