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Atropine Sulfate Injection

Last Updated: April 20, 2018
Status: Current

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, 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
    • Atropine Sulfate injection, West-Ward, 0.4 mg/mL, 20 mL multiple dose vial, 10 count, NDC 00641-6006-10
Reason for the Shortage
    • American Regent had atropine injection on shortage due to market demand.
    • Amphastar has atropine injection available.
    • Pfizer has atropine injection on shortage due to manufacturing delays.
    • West-Ward did not provide a reason for the shortage.
Available Products
    • Atropine Sulfate injection, Amphastar, 0.1 mg/mL, 10 mL Luer-Jet syringe, 10 count, NDC 76329-3339-01
    • Atropine Sulfate injection, Pfizer, 0.05 mg/mL, 5 mL Ansyr syringe, 10 count, NDC 00409-9630-05

Estimated Resupply Dates

    • American Regent has 1 mg/mL 1 mL vials available in limited quantities. The 0.4 mg/mL 1 mL vials are on back order and the company cannot estimate a release date.
    • Pfizer has atropine 0.1 mg/mL 10 mL Ansyr syringes available on back order and the company estimates a release date of June 2018. The 0.1 mg/mL 5 mL LifeShield syringes are on back order and the company estimates a release date of early-May 2018. The 0.1 mg/mL 10 mL LifeShield syringes are on back order and the company estimates a release date of May 2018.
    • West-Ward has atropine 0.4 mg/mL 20 mL vials on allocation.

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 April 20, 2018 by Michelle Wheeler, PharmD, Drug Information Specialist. Created August 2, 2011 by Michelle Wheeler, PharmD, Drug Information Specialist. Copyright 2018, Drug Information Service, University of Utah, Salt Lake City, UT.

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