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8/7/2019

Asparaginase Erwinia chrysanthemi

Products Affected - Description

    • Erwinaze lyophilized powder for injection, Jazz Pharmaceuticals, 10,000 unit, vial, 1 count, NDC 57902-0249-01
    • Erwinaze lyophilized powder for injection, Jazz Pharmaceuticals, 10,000 unit, vial, 5 count, NDC 57902-0249-05

Reason for the Shortage

    • Jazz Pharmaceuticals did not provide a reason for the shortage.

Available Products

    • There are no presentations available

Estimated Resupply Dates

    • Jazz Pharmaceuticals has Erwinaze 10,000 unit vials in 1 count and 5 count on back order and the company estimates a release date of mid-August 2019.
    • There is a new process for ordering Erwinaze. Additional information regarding the new ordering process is available at www.erwinazesupply.com.

Safety

    • Jazz Pharmaceuticals sent Dear Health Care Provider letters regarding the administration of certain batches of Erwinaze (Batches 192K, 174K, 177K, 178K, 179K, 180K, 181K, 182K, 183K, 184K, 185K, 185ak, 186K, 187K, 188K, 189K,190K, and 191K). Particulate matter was seen in vials from these batches during routine inspections. Jazz states that these batches must be given intramuscularly only and NOT intravenously. Batch 191K may be given either intramuscularly or intravenously via tubing with a 0.2-micron, low-protein-binding, in-line filter. Use 5-micron filter needles when withdrawing Erwinaze from vials. The most recent letter with further details can be found at https://www.fda.gov/downloads/Drugs/DrugSafety/DrugShortages/UCM632096.pdf.

Updated

Updated August 7, 2019 by Leslie Jensen, PharmD, Drug Information Specialist. Created October 11, 2018 by Michelle Wheeler, PharmD, Drug Information Specialist. © 2019, Drug Information Service, University of Utah, Salt Lake City, UT.

Disclaimer

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