Mitomycin-C Injectable Syringes Recalled for Sterility Assurance Failure
Edge Pharma is recalling Mitomycin-C 40 mg/40 mL single-dose syringes (NDC 05446-1416-01) nationwide due to lack of assurance of sterility. Approximately 860 syringes are affected.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class II recall of a sterile injectable drug product. Loss of sterility assurance for an intravesical medication poses serious risk of infection and complications; the FDA classification combined with the nature of the hazard (lack of sterility in a parenteral product) meets the Severe threshold.
Plain-English summary
Edge Pharma, LLC is recalling Mitomycin-C, 40 mg/40 mL (1 mg/mL) in 40 mL single-dose syringes for intravesical use. The recall was issued because the manufacturer cannot assure sterility of the affected product batches.
The affected product is manufactured by Edge Pharma, LLC, located at 856 Hercules Drive, Colchester, Vermont 05446, with NDC number 05446-1416-01. Approximately 860 syringes have been distributed nationwide with the following lot codes: 08-2021-24@5 (12/09/2021), 08-2021-27@2 (12/21/2021), 08-2021-31@5 (12/14/2021), 09-2021-02@2 (12/15/2021), 09-2021-09@2 (12/22/2021), 09-2021-15@3 (12/29/2021), 09-2021-22@2 (01/04/2022), and 10-2021-26@5 (02/07/2022).
Patients who have received doses from the recalled syringes should consult their healthcare provider. Healthcare providers should stop using the affected lot codes immediately and contact their supplier for replacement product.
The recalled product
- Product
- Mitomycin-C, 40mg/40mL (1mg/mL), 40 mL per syringe, Single Dose Syringe for Intravesical Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1416-01
- Manufacturer
- Edge Pharma, LLC
- Category
- Drug — Injectable / Intravesical
- Affected units
- 860
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 (7)
- 08-2021-24@5 12/09/2021
- 08-2021-27@2 12/21/2021
- 08-2021-31@5 12/14/2021
- 09-2021-02@2 12/15/2021
- 09-2021-09@2 12/22/2021
- 09-2021-15@3 12/29/2021
- 09-2021-22@2 01/04/2022 & 10-2021-26@5 02/07/2022
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 56 recalled by Edge Pharma, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 56 products in this recall →Related recalls
Same manufacturer · Edge Pharma, LLC
See all →- ModerateProfound-PE Dental Gel Recalled for Manufacturing Deviations
FDA (Drugs) · 2022-02-02
- SevereMVASI Sterile Ophthalmic Solution Lacks Assured Sterility
FDA (Drugs) · 2022-02-02
- ModerateLET Topical Gel drug recall for CGMP deviations
FDA (Drugs) · 2022-02-02
- SevereVancomycin HCl Injection Recalled for Sterility Assurance Issues
FDA (Drugs) · 2022-02-02
- ModerateCSF-HC Otic Powder Drug Recalled for Manufacturing Deviations
FDA (Drugs) · 2022-02-02
Same hazard · lack of sterility
See all →- HighRohto Cooling Eye Drops Max Strength Recalled Due to Sterility Concerns
FDA (Drugs) · 2026-07-29
- HighRohto Cooling Eye Drops Recalled Due to Lack of Assurance of Sterility
FDA (Drugs) · 2026-07-29
- SevereCleviprex Injectable Emulsion Recall Due to Sterility Assurance Concerns
FDA (Drugs) · 2026-07-22
- SeverePemetrexed for Injection recalled due to lack of sterility assurance
FDA (Drugs) · 2026-07-15
- SevereAzacitidine for Injection Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2026-07-15