Recalls / Class II
Class IID-0407-2022
Product
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
- Affected lot / code info
- 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
Why it was recalled
Lack of Assurance of Sterility
Recalling firm
- Firm
- Edge Pharma, LLC
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 856 Hercules Dr, Colchester, Vermont 05446-8014
Distribution
- Quantity
- 860 syringes
- Distribution pattern
- nationwide
Timeline
- Recall initiated
- 2021-12-06
- FDA classified
- 2022-01-24
- Posted by FDA
- 2022-02-02
- Terminated
- 2023-06-07
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0407-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.