FDA recall D-0454-2023
Akron Pharma, Inc. · Class III · drug
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
- 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
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0454-2023