4/28/2023

Mitomycin Injection

Products Affected - Description

- Mutamycin lyophilized powder for injection, Accord, 20 mg vial, 1 count, NDC 69448-0002-11
- Mutamycin lyophilized powder for injection, Accord, 40 mg vial, 1 count, NDC 69448-0003-38
- Mutamycin lyophilized powder for injection, Accord, 5 mg vial, 1 count, NDC 69448-0001-05
- Mitomycin lyophilized powder for injection, Accord, 20 mg vial, 1 count, NDC 16729-0108-11
- Mitomycin lyophilized powder for injection, Accord, 40 mg vial, 1 count, NDC 16729-0116-38
- Mitomycin lyophilized powder for injection, Accord, 5 mg vial, 1 count, NDC 16729-0115-05
- Mitomycin lyophilized powder for injection, Hikma, 20 mg vial, 1 count, NDC 00143-9279-01
- Mitomycin lyophilized powder for injection, Hikma, 40 mg vial, 1 count, NDC 00143-9280-01

Reason for the Shortage

- Accord has mitomycin injection on shortage due to manufacturing delays.
- Hikma did not provide a reason for the shortage.
- Archis has mitomycin injection available.
- Fresenius Kabi has mitomycin injection available.

Available Products

- Mitomycin lyophilized powder for injection, Archis Pharma, 20 mg vial, 1 count, NDC 67457-0519-20
- Mitomycin lyophilized powder for injection, Archis Pharma, 40 mg vial, 1 count, NDC 67457-0520-40
- Mitomycin lyophilized powder for injection, Archis Pharma, 5 mg vial, 1 count, NDC 72819-0152-95
- Mitomycin lyophilized powder for injection, Fresenius Kabi, 20 mg vial, 1 count, NDC 65219-0566-20
- Mitomycin lyophilized powder for injection, Fresenius Kabi, 40 mg vial, 1 count, NDC 65219-0568-00
- Mitomycin lyophilized powder for injection, Fresenius Kabi, 5 mg vial, 1 count, NDC 65219-0564-20
- Mitomycin lyophilized powder for injection, Meitheal Pharmaceuticals, 20 mg vial, 1 count, NDC 71288-0138-50
- Mitomycin lyophilized powder for injection, Meitheal Pharmaceuticals, 40 mg vial, 1 count, NDC 71288-0139-51
- Mitomycin lyophilized powder for injection, Meitheal Pharmaceuticals, 5 mg vial, 1 count, NDC 71288-0137-20

Estimated Resupply Dates

- Accord has all mitomycin presentations on back order and the company cannot estimate a release date.
- Accord has all Mutamycin presentations on back order and the company cannot estimate a release date.
- Hikma has mitomycin 20 mg and 40 mg vials on back order and the company estimates a release date of late-May to early-June 2023.

Updated

Updated April 28, 2023 by Michelle Wheeler, PharmD, Drug Information Specialist. Created March 3, 2023 by Michelle Wheeler, PharmD, Drug Information Specialist. © 2023, Drug Information Service, University of Utah, Salt Lake City, UT.

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