Recalls / Class III
Class IIID-0454-2023
Product
DIBUCAINE 1% HEMORRHOIDAL OINTMENT, 1 oz. (28 gm), Manufactured for: Akron Pharma Inc. Fairfield NJ 07004, NDC 71399-2829-1
- Brand name
- Dibucaine
- Generic name
- Dibucaine
- Active ingredient
- Dibucaine
- Route
- Topical
- NDC
- 71399-2829
- FDA application
- M015
- Affected lot / code info
- Lot #: 2206016, Exp. date 05/2024
Why it was recalled
Labeling: Incorrect or Missing Lot and/or Exp Date
Recalling firm
- Firm
- Akron Pharma, Inc.
- Manufacturer
- Akron Pharma Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 373 Us Highway 46 Ste 117, Fairfield, New Jersey 07004-2456
Distribution
- Quantity
- 4,416 tubes
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2023-02-17
- FDA classified
- 2023-03-09
- Posted by FDA
- 2023-03-15
- Terminated
- 2024-09-09
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0454-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.