D-0403-2022 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- February 2, 2022
- Initiation Date
- December 6, 2021
- Termination Date
- June 7, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 627 syringes
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
Reason for Recall
Lack of Assurance of Sterility
Distribution Pattern
nationwide
Code Information
08-2021-18@1 12/14/2021, 08-2021-27@1 12/09/2021, 09-2021-01@4 12/14/2021, 09-2021-08@2 12/21/2021, 09-2021-14@6 01/05/2021, 09-2021-16@4 12/29/2021, 09-2021-17@4 12/30/2021, 09-2021-22@3 01/04/2022 & 10-2021-27@3 02/08/2022