Why it was recalled
Lack of Assurance of Sterility
Product description
Mitomycin-C, 40mg/40mL (1mg/mL), 40 mL per syringe, Single Dose Syringe for Intravesical Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1416-01
Lot numbers, UPCs & expiration codes
08-2021-24@5 12/09/2021, 08-2021-27@2 12/21/2021, 08-2021-31@5 12/14/2021, 09-2021-02@2 12/15/2021, 09-2021-09@2 12/22/2021, 09-2021-15@3 12/29/2021, 09-2021-22@2 01/04/2022 & 10-2021-26@5 02/07/2022
Where it was sold
nationwide
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-0407-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Dec 6, 2021
- FDA report date
- Feb 2, 2022
- Quantity
- 860 syringes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Edge Pharma, LLC
Original FDA data
Every field from FDA enforcement report D-0407-2022, exactly as published.
Show all FDA fields
- City
- Colchester
- State
- VT
- Status
- Terminated
- Country
- United States
- Event ID
- 89172
- Address
- 856 Hercules Dr
- Code information
- 08-2021-24@5 12/09/2021, 08-2021-27@2 12/21/2021, 08-2021-31@5 12/14/2021, 09-2021-02@2 12/15/2021, 09-2021-09@2 12/22/2021, 09-2021-15@3 12/29/2021, 09-2021-22@2 01/04/2022 & 10-2021-26@5 02/07/2022
- Postal code
- 05446-8014
- Report date
- Feb 2, 2022
- Product type
- Drugs
- Recall number
- D-0407-2022
- Classification
- Class II
- Recalling firm
- Edge Pharma, LLC
- Product quantity
- 860 syringes
- Termination date
- Jun 7, 2023
- Reason for recall
- Lack of Assurance of Sterility
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Mitomycin-C, 40mg/40mL (1mg/mL), 40 mL per syringe, Single Dose Syringe for Intravesical Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1416-01
- Distribution pattern
- nationwide
- Recall initiation date
- Dec 6, 2021
- Initial firm notification
- Press Release
- Center classification date
- Jan 24, 2022