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5/1/2020

Atropine Sulfate Injection

Products Affected - Description

    • Atropine Sulfate injection, American Regent, 0.4 mg/mL, 1 mL single dose vial, 25 count, NDC 00517-0401-25
    • Atropine Sulfate injection, American Regent, 1 mg/mL, 1 mL single dose vial, 25 count, NDC 00517-1010-25
    • Atropine Sulfate injection, Hikma, 0.4 mg/mL, 20 mL multiple dose vial, 10 count, NDC 00641-6006-10
    • 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, 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 had atropine injection on shortage due to market demand.
    • Amphastar has atropine injection on shortage due to increased demand.
    • Fresenius Kabi has atropine injection available.
    • Hikma has atropine injection available.
    • Pfizer has atropine injection on shortage due to manufacturing delays.

Available Products

    • 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

Estimated Resupply Dates

    • American Regent has atropine 0.4 mg/mL 1 mL vials and 1 mg/mL 1 mL vials available in limited supply.
    • Hikma has atropine 0.4 mg/mL 20 mL vials on allocation.
    • Pfizer has atropine 0.1 mg/mL 5 mL and 10 mL LifeShield syringes available in limited supply. The 0.1 mg/mL 10 mL Ansyr syringes are available in limited supply. The 0.05 mg/mL 5 mL Ansyr syringes are available in limited supply.

Safety

    • FDA has extended the expiration dating for certain lots of atropine 0.1 mg/mL 5 mL and 10 mL Abboject syringes. https://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm563360.htm

Updated

Updated May 1, 2020 by Michelle Wheeler, PharmD, Drug Information Specialist. Created August 2, 2011 by Michelle Wheeler, PharmD, Drug Information Specialist. © 2020, 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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