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6/9/2022

Zoledronic Acid Injection

Products Affected - Description

    • Zoledronic Acid intravenous solution for injection, Athenex, 4 mg/100 mL, 100 mL bottle, NDC 70860-0210-51
    • Zoledronic Acid intravenous solution for injection, Dr. Reddy's, 5 mg/100 mL, 100 mL bottle, NDC 55111-0688-52
    • Zoledronic Acid intravenous concentrate, Pfizer, 4 mg/5 mL, 5 mL single dose vial, NDC 00409-4215-01
    • Zoledronic Acid intravenous concentrate, Sagent, 4 mg/5 mL, 5 mL single dose vial, NDC 25021-0801-66
    • Zoledronic Acid intravenous solution for injection, Sagent, 4 mg/100 mL, 100 mL bag, NDC 25021-0826-82

Reason for the Shortage

    • Athenex did not provide a reason for the shortage.
    • Dr. Reddy's did not provide a reason for the shortage.
    • Fresenius Kabi has zoledronic acid 5 mg/100 mL injection available.
    • Mylan has zoledronic acid 5 mg/100 mL injection available.
    • Novartis has Reclast 5 mg/100 mL bottles available.
    • Pfizer has zoledronic acid 4 mg/5 mL on back order due to manufacturing delays.
    • Sagent did not provide a reason for the shortage.

Available Products

    • Reclast intravenous solution for injection, Novartis, 5 mg/100 mL, 100 mL bottle, NDC 00078-0435-61
    • Zoledronic Acid intravenous concentrate, Dr. Reddy's, 4 mg/5 mL, 5 mL single dose vial, NDC 55111-0685-07
    • Zoledronic Acid intravenous concentrate, Fresenius Kabi, 4 mg/5 mL, 5 mL single dose vial, NDC 63323-0961-98
    • Zoledronic Acid intravenous solution for injection, Fresenius Kabi, 5 mg/100 mL, 100 mL glass vial, NDC 63323-0966-00
    • Zoledronic Acid intravenous concentrate, Mylan, 4 mg/5 mL, 5 mL single dose vial, NDC 67457-0390-54
    • Zoledronic Acid intravenous solution for injection, Mylan, 5 mg/100 mL, 100 mL bag, NDC 67457-0794-10
    • Zoledronic Acid intravenous solution for injection, Mylan, 5 mg/100 mL, 100 mL vial, NDC 67457-0619-10
    • Zoledronic Acid intravenous solution for injection, Sagent, 5 mg/100 mL, 100 mL bag, NDC 25021-0830-82

Estimated Resupply Dates

    • Athenex has zoledronic acid 4 mg/100 mL bottles on back order and the company estimates a release date in mid-June 2022.
    • Dr. Reddy's has zoledronic acid 5 mg/100 mL bottles on intermittent back order and the company is releasing supplies as they become available.
    • Pfizer has zoledronic acid on back order and the company estimates a release date in April 2023.
    • Sagent has zoledronic acid 4 mg/100 mL bags on allocation. The 4 mg/5 mL vials are available with short expiration dating (August 2022).

Updated

Updated June 9, 2022 by Leslie Jensen, PharmD, Drug Information Specialist. Created January 21, 2022 by Leslie Jensen, PharmD, Drug Information Specialist. © 2022, Drug Information Service, University of Utah, Salt Lake City, UT.

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