The Recall Desk
SevereFDA (Drugs)·D-0407-2022·Announced 2022-02-02

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
Hazard
  • lack-of-sterility
  • infection-risk
  • contamination

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.

Related recalls

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