Agency classClass IIOur severity:Severe FDA (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.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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
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 →

Same manufacturer · Edge Pharma, LLC

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