Gemcitabine, Sterile Intravesical Solution, Preservative Free, 1g/50mL (20 mg/mL), 50 mL per syri...
FDA Recall #D-0403-2022 — Class II — December 6, 2021
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
Recalling Firm
Edge Pharma, LLC — Colchester, VT
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
627 syringes
Distribution
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
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated