FDA Drug recall D-0403-2022
Gemcitabine, Sterile Intravesical Solution, Preservative Free, 1g/50mL (20 mg/mL), 50 mL per syringe, Single Dose Syringe for Intravesical…
- FDA Drug
- Class II
- terminated
- Published 2022-02-02
On 2022-02-02 the FDA classified a Class II recall of Gemcitabine, Sterile Intravesical Solution, Preservative Free, 1g/50mL (20 mg/mL), 50 mL per syringe, Single Dose Syringe for Intravesical… by Edge Pharma, citing lack of Assurance of Sterility.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0403-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-12-06 |
| Published | 2022-02-02 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Edge Pharma |
| Distribution | US |
Product
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
Lack of Assurance of Sterility
Identifiers
| code_info | 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…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 history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0403-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.