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Atropine Sulfate Injection Shortage

Last Updated: September 12, 2024
Status: Current

Products Affected - Description
    • Atropine Sulfate injection, Fresenius Kabi, 0.4 mg/mL, 20 mL multiple dose vial, 10 count, NDC 63323-0580-20
    • Atropine Sulfate injection, Hikma, 0.4 mg/mL, 20 mL multiple dose vial, 10 count, NDC 00641-6251-10
    • Atropine Sulfate injection, Pfizer, 0.1 mg/mL, 10 mL 21 gauge LifeShield syringe, 10 count, NDC 00409-4911-34
    • Atropine Sulfate injection, Pfizer, 0.1 mg/mL, 5 mL LifeShield syringe, 10 count, NDC 00409-4910-34
Reason for the Shortage
    • American Regent has atropine injection available.
    • Amneal has atropine injection available.
    • Amphastar has atropine injection available.
    • Fresenius Kabi did not provide a reason for the shortage.
    • Hikma did not provide a reason for the shortage.
    • Medefil has atropine injection available.
    • Pfizer has atropine injection on shortage due to manufacturing delays.
    • Somerset has atropine injection available.
Available Products
    • Atropine Sulfate injection, American Regent, 0.4 mg/mL, 1 mL single dose vial, 25 count, NDC 00517-1004-25
    • Atropine Sulfate injection, American Regent, 1 mg/mL, 1 mL single dose vial, 25 count, NDC 00517-1001-25
    • Atropine Sulfate injection, Amneal, 0.1 mg/mL, 10 mL syringe, 10 count, NDC 70121-1706-02
    • Atropine Sulfate injection, Amneal, 0.1 mg/mL, 5 mL syringe, 10 count, NDC 70121-1705-07
    • Atropine Sulfate injection, Amphastar, 0.1 mg/mL, 10 mL Luer-Jet syringe, 10 count, NDC 76329-3339-01
    • Atropine Sulfate injection, Medefil, Inc., 0.1 mg/mL, 10 mL syringe, 10 count, NDC 64253-0400-91
    • Atropine Sulfate injection, Pfizer, 0.05 mg/mL, 5 mL Ansyr syringe, 10 count, NDC 00409-9630-05
    • Atropine Sulfate injection, Pfizer, 0.1 mg/mL, 10 mL Ansyr syringe, 10 count, NDC 00409-1630-10
    • Atropine Sulfate injection, Somerset Therapeutics LLC, 0.4 mg/mL, 1 mL single dose vial, 25 count, NDC 70069-0631-25
    • Atropine Sulfate injection, Somerset Therapeutics LLC, 1 mg/mL, 1 mL single dose vial, 25 count, NDC 70069-0641-25

Estimated Resupply Dates

    • Hikma has atropine 0.4 mg/mL 20 mL vials on back order and the company estimates a release date of late-October to early-November 2024.
    • Pfizer has atropine 0.1 mg/mL 5 mL LifeShield syringes and 0.1 mg/mL 10 mL LifeShield syringes on back order and the company estimates a release date of January 2026.
    • Fresenius Kabi has short-dated atropine 0.4 mg/mL 20 mL vials available with an expiration date of < 2 months.

Updated

Updated September 12, 2024 by Michelle Wheeler, PharmD, Drug Information Specialist. Created August 2, 2011 by Michelle Wheeler, PharmD, Drug Information Specialist. © 2024, Drug Information Service, University of Utah, Salt Lake City, UT.

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