Edge Pharma, LLC: Drug Recall
Recall #D-0403-2022 · 12/06/2021
Class II: Risk
Recall Details
- Recall Number
- D-0403-2022
- Classification
- Class II
- Product Type
- Drug
- Recalling Firm
- Edge Pharma, LLC
- Status
- Terminated
- Date Initiated
- 12/06/2021
- Location
- Colchester, VT, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 627 syringes
Reason for Recall
Lack of Assurance of Sterility
Product Description
Gemcitabine, Sterile Intravesical Solution, Preservative Free, 1g/50mL (20 mg/mL), 50 mL per syringe, Single Dose Syringe for Intravesical Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1566-50
Distribution Pattern
nationwide
Other Recalls by Edge Pharma, LLC
- Class II: Risk 12/06/2021
- Class II: Risk 12/06/2021
- Class II: Risk 12/06/2021
- Class II: Risk 12/06/2021
- Class II: Risk 12/06/2021
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.