The Recall Desk
HighFDA (Drugs)·D-0403-2022·Announced 2022-02-02

Gemcitabine Intravesical Solution Recalled for Lack of Sterility Assurance

Edge Pharma is recalling approximately 627 syringes of Gemcitabine Sterile Intravesical Solution nationwide because the manufacturer cannot guarantee the product is sterile. The recalled batches were distributed between December 2021 and February 2022.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall of a sterile injectable drug where the primary hazard is potential microbial contamination from lack of sterility assurance. Although no illnesses or injuries are reported in the source text, the product is used intravesically (directly into the bladder) and lack of sterility poses a direct risk of serious infection in high-risk patient populations. This hazard profile and product route of administration justify a High severity rating.

Plain-English summary

Edge Pharma, LLC is recalling Gemcitabine, Sterile Intravesical Solution, Preservative Free (1g/50mL, 20 mg/mL) in single-dose 50 mL syringes due to lack of assurance of sterility. The recalled product includes 627 syringes distributed nationwide, with lot codes dating from December 2021 to February 2022.

The recall affects the product NDC 05446-1566-50 manufactured at Edge Pharma's facility in Colchester, Vermont. Because the sterility of these syringes cannot be assured, patients who receive the product may be at risk of infection.

Consumers and healthcare providers who have received affected batches should discontinue use immediately. Anyone with questions about whether they have received a recalled batch should contact Edge Pharma directly or consult their healthcare provider.

The recalled product

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
Manufacturer
Edge Pharma, LLC
Category
Drug — Injectable Solution
Hazard
  • sterility-failure
  • contamination-risk
  • infection-risk

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (8)

  • 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

Distribution

Distributed nationwide across the United States.

Related recalls

Same category