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
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Edge Pharma, LLC
- Reason for Recall:
- Lack of Assurance of Sterility
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full 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
Product Codes/Lot Numbers:
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
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: D-0403-2022
Related Recalls
Lack of Assurance of Sterility.
Lack of Assurance of Sterility
Lack of Assurance of Sterility