D-0454-2023 Class III Terminated
FDA drug recall D-0454-2023 was initiated by Akron Pharma, Inc. on February 17, 2023 and is designated Class III. Reason for recall: Labeling: Incorrect or Missing Lot and/or Exp Date The recall status is terminated (terminated September 9, 2024). Affected quantity: 4,416 tubes.
Recall Details
- Product Type
- Drugs
- Report Date
- March 15, 2023
- Initiation Date
- February 17, 2023
- Termination Date
- September 9, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4,416 tubes
Product Description
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 Pattern
Nationwide within the United States
Code Information
Lot #: 2206016, Exp. date 05/2024