Products Affected - Description

• • Dobutamine injection, Pfizer, 1 mg/mL, 250 mL premixed bag, 12 count, NDC 00409-2346-32
  • Dobutamine injection, Pfizer, 12.5 mg/mL, 20 mL vial, 1 count, NDC 00409-2344-01
  • Dobutamine injection, Pfizer, 2 mg/mL, 250 mL premixed bag, 12 count, NDC 00409-2347-32
  • Dobutamine injection, Pfizer, 4 mg/mL, 250 mL premixed bag, 12 count, NDC 00409-3724-32

Reason for the Shortage

• • Baxter had dobutamine on shortage due to manufacturing delays of a third-party supplier.
  • Pfizer has dobutamine on shortage due to manufacturing delays. FDA has approved extended expiry for several dobutamine presentations. These will be available at https://www.fda.gov/drugs/drug-shortages/search-list-extended-use-dates-assist-drug-shortages.

Available Products

• • Dobutamine injection, Baxter, 1 mg/mL, 250 mL premixed bag, 12 count, NDC 00338-1073-02
  • Dobutamine injection, Baxter, 2 mg/mL, 250 mL premixed bag, 12 count, NDC 00338-1075-02
  • Dobutamine injection, Baxter, 4 mg/mL, 250 mL premixed bag, 12 count, NDC 00338-1077-02
  • Dobutamine injection, Pfizer, 12.5 mg/mL, 20 mL vial, 10 count, NDC 00409-2344-02

• • Pfizer has dobutamine 1 mg/mL 250 mL premixed bags on back order and the company estimates a release date of May 2023. The 2 mg/mL 250 mL premixed bags are on back order and the company estimates a release date of June 2023. The 4 mg/mL 250 mL premixed bags are available in limited supply. The 12.5 mg/mL 20 mL vials in 1 count are on back order and the company estimates a release date of June 2023.

• • Additional information can be found in a guidance document at: https://www.acc.org/Latest-in-Cardiology/Articles/2022/08/02/12/42/What-You-Need-to-Know-Guidance-For-Clinicians-on-Dobutamine-Shortage