Why it was recalled
Labeling: Incorrect or Missing Lot and/or Exp Date
Product description
DIBUCAINE 1% HEMORRHOIDAL OINTMENT, 1 oz. (28 gm), Manufactured for: Akron Pharma Inc. Fairfield NJ 07004, NDC 71399-2829-1
Lot numbers, UPCs & expiration codes
Lot #: 2206016, Exp. date 05/2024
Where it was sold
Nationwide within the United States
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0454-2023
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Feb 17, 2023
- FDA report date
- Mar 15, 2023
- Quantity
- 4,416 tubes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Akron Pharma, Inc.
Original FDA data
Every field from FDA enforcement report D-0454-2023, exactly as published.
Show all FDA fields
- City
- Fairfield
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 91785
- Address
- 373 Us Highway 46 Ste 117
- Code information
- Lot #: 2206016, Exp. date 05/2024
- Postal code
- 07004-2456
- Report date
- Mar 15, 2023
- Product type
- Drugs
- Recall number
- D-0454-2023
- Classification
- Class III
- Recalling firm
- Akron Pharma, Inc.
- Product quantity
- 4,416 tubes
- Termination date
- Sep 9, 2024
- Reason for recall
- Labeling: Incorrect or Missing Lot and/or Exp Date
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- DIBUCAINE 1% HEMORRHOIDAL OINTMENT, 1 oz. (28 gm), Manufactured for: Akron Pharma Inc. Fairfield NJ 07004, NDC 71399-2829-1
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Feb 17, 2023
- Initial firm notification
- Letter
- Center classification date
- Mar 9, 2023