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4/1/2024

Atropine Sulfate Injection

Products Affected - Description

    • 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 Ansyr syringe, 10 count, NDC 00409-1630-10
    • 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.
    • Amphastar has atropine injection available.
    • Fresenius Kabi has atropine injection available.
    • Hikma did not provide a reason for the shortage.
    • Medefil has atropine injection available.
    • Pfizer has atropine injection on shortage due to manufacturing delays.

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, Amphastar, 0.1 mg/mL, 10 mL Luer-Jet syringe, 10 count, NDC 76329-3339-01
    • Atropine Sulfate injection, Fresenius Kabi, 0.4 mg/mL, 20 mL multiple dose vial, 10 count, NDC 63323-0580-20
    • Atropine Sulfate injection, Medefil, Inc., 0.1 mg/mL, 10 mL syringe, 10 count, NDC 64253-0400-30
    • Atropine Sulfate injection, Pfizer, 0.05 mg/mL, 5 mL Ansyr syringe, 10 count, NDC 00409-9630-05

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-April to early-May 2024.
    • Pfizer has atropine 0.1 mg/mL 10 mL Ansyr syringes and 0.1 mg/mL 10 mL LifeShield syringes on back order and the company estimates a release date of May 2024 for the 0.1 mg/mL Ansyr syringes and June 2024 for the 0.1 mg/mL 10 mL LifeShield syringes. The 0.1 mg/mL 5 mL LifeShield syringes are available for emergency use via direct orders only.

Updated

Updated April 1, 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.

Disclaimer

Drug Shortage Bulletins are copyrighted by the Drug Information Service of the University of Utah and provided by ASHP as its exclusive authorized distributor. ASHP and the University of Utah make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information, and specifically disclaim all such warranties. Users of this information are advised that decisions regarding the use of drugs and drug therapies are complex medical decisions and that in using this information, each user must exercise his or her own independent professional judgment. Neither ASHP nor the University of Utah assumes any liability for persons administering or receiving drugs or other medical care in reliance upon this information, or otherwise in connection with this Bulletin. Neither ASHP nor the University of Utah endorses or recommends the use of any particular drug. Any application of this information for any purpose shall be limited to personal, non-commercial use.

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