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8/12/2019

Atropine Sulfate Injection

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 00641-6006-10
    • 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, 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, Amphastar, 0.1 mg/mL, 10 mL Luer-Jet syringe, 10 count, NDC 76329-3339-01

Estimated Resupply Dates

    • Fresenius Kabi has short-dated atropine 0.4 mg/mL 20 mL vials with an expiration date of <8 months.
    • Hikma has short-dated atropine 0.4 mg/mL 20 mL vials available with an expiration date of June 2020.
    • Pfizer has atropine 0.1 mg/mL 10 mL LifeShield syringes on back order and the company estimates release dates of September 2019. The 0.1 mg/mL 10 mL Ansyr syringes are on back order and the company estimates a release date of December 2019. The 0.1 mg/mL 5 mL LifeShield syringes are on back order and the company estimates release dates of October 2019. The 0.05 mg/mL 5 mL Ansyr syringes are available with an expiration date of December 2019.

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 August 12, 2019 by Michelle Wheeler, PharmD, Drug Information Specialist. Created August 2, 2011 by Michelle Wheeler, PharmD, Drug Information Specialist. © 2019, Drug Information Service, University of Utah, Salt Lake City, UT.

Disclaimer

This information is provided through the support of Vizient to ASHP solely as a service to its members, which shall not use this information for their further commercial use. The content was prepared by the Drug Information Center of University of Utah. Vizient, 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, which 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 Vizient, 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 Vizient, ASHP nor University of Utah endorses or recommends the use of any drug.

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