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7/10/2019

Heparin Injection

Products Affected - Description

    • Heparin Sodium solution for injection, Fresenius Kabi, 1,000 unit/mL, 1 mL multiple dose vial, 25 count, NDC 63323-0540-01
    • Heparin Sodium solution for injection, Fresenius Kabi, 1,000 unit/mL, 10 mL multiple dose vial, 25 count, NDC 63323-0540-11
    • Heparin Sodium solution for injection, Fresenius Kabi, 1,000 unit/mL, 2 mL single dose vial, 25 count, NDC 63323-0276-02
    • Heparin Sodium solution for injection, Fresenius Kabi, 1,000 unit/mL, 30 mL multiple dose vial, 25 count, NDC 63323-0540-31
    • Heparin Sodium solution for injection, Fresenius Kabi, 10,000 unit/mL, 0.5 mL preservative-free vial, 25 count, NDC 63323-0543-02
    • Heparin Sodium solution for injection, Fresenius Kabi, 10,000 unit/mL, 1 mL multiple dose vial, 25 count, NDC 63323-0542-01
    • Heparin Sodium solution for injection, Fresenius Kabi, 10,000 unit/mL, 4 mL multiple dose vial, 25 count, NDC 63323-0459-09
    • Heparin Sodium solution for injection, Fresenius Kabi, 10,000 unit/mL, 5 mL multiple dose vial, 25 count, NDC 63323-0542-07
    • Heparin Sodium solution for injection, Fresenius Kabi, 20,000 unit/mL, 1 mL multiple dose vial, 25 count, NDC 63323-0915-01
    • Heparin Sodium solution for injection, Fresenius Kabi, 5,000 unit/mL, 1 mL multiple dose vial, 25 count, NDC 63323-0262-01
    • Heparin Sodium solution for injection, Fresenius Kabi, 5,000 unit/mL, 1 mL prefilled syringe, 24 count, NDC 76045-0108-10
    • Heparin Sodium solution for injection, Fresenius Kabi, 5,000 unit/mL, 10 mL multiple dose vial, 25 count, NDC 63323-0047-10
    • Heparin Sodium solution for injection, Hikma, 1,000 unit/mL, 1 mL single dose vial, 25 count, NDC 00641-0391-12
    • Heparin Sodium solution for injection, Hikma, 10,000 unit/mL, 1 mL single dose vial, 25 count, NDC 00641-0410-12
    • Heparin Sodium solution for injection, Hikma, 5,000 unit/mL, 1 mL single dose vial, 25 count, NDC 00641-0400-12
    • Heparin Sodium solution for injection, Pfizer, 1,000 unit/mL, 10 mL multiple dose vial, 25 count, NDC 00409-2720-02
    • Heparin Sodium solution for injection, Pfizer, 1,000 unit/mL, 10 mL multiple dose vial, 25 count, NDC 00069-0058-01
    • Heparin Sodium solution for injection, Pfizer, 1,000 unit/mL, 2 mL single dose vial, 25 count, NDC 00069-0043-01 - discontinued
    • Heparin Sodium solution for injection, Pfizer, 1,000 unit/mL, 30 mL multiple dose vial, 10 count, NDC 00069-0137-03
    • Heparin Sodium solution for injection, Pfizer, 1,000 unit/mL, 30 mL multiple dose vial, 25 count, NDC 00409-2720-03
    • Heparin Sodium solution for injection, Pfizer, 10,000 unit/mL, 0.5 mL preservative-free Carpuject syringe, 50 count, NDC 00409-1316-32
    • Heparin Sodium solution for injection, Pfizer, 10,000 unit/mL, 1 mL multiple dose vial, 25 count, NDC 00069-0062-01 - discontinued
    • Heparin Sodium solution for injection, Pfizer, 10,000 unit/mL, 1mL single dose vial, 25 count, NDC 00409-2721-01
    • Heparin Sodium solution for injection, Pfizer, 5,000 unit/mL, 10 mL multiple dose vial, 25 count, NDC 00409-2723-02
    • Heparin Sodium solution for injection, Pfizer, 5,000 unit/mL, 1mL Carpuject syringe, 50 count, NDC 00409-1402-12
    • Heparin Sodium solution for injection, Pfizer, 5,000 unit/mL, 1mL single dose vial, 25 count, NDC 00409-2723-01
    • Heparin Sodium solution for injection, Sagent, 1,000 unit/mL, 1 mL vial, 25 count, NDC 25021-0400-01
    • Heparin Sodium solution for injection, Sagent, 1,000 unit/mL, 10 mL multiple dose vial, 25 count, NDC 25021-0400-10
    • Heparin Sodium solution for injection, Sagent, 1,000 unit/mL, 2 mL single dose vial, 25 count, NDC 25021-0401-02
    • Heparin Sodium solution for injection, Sagent, 10,000 unit/mL, 1 mL vial, 25 count, NDC 25021-0403-01
    • Heparin Sodium solution for injection, Sagent, 10,000 unit/mL, 4 mL multiple dose vial, 25 count, NDC 25021-0403-04
    • Heparin Sodium solution for injection, Sagent, 20,000 unit/mL, 1mL multiple dose vial, 25 count, NDC 25021-0404-01
    • Heparin Sodium solution for injection, Sagent, 5,000 unit/mL, 1 mL vial, 25 count, NDC 25021-0402-01
    • Heparin Sodium solution for injection, Sagent, 5,000 unit/mL, 10 mL multiple dose vial, 25 count, NDC 25021-0402-10

Reason for the Shortage

    • Fresenius Kabi has put heparin on a protective allocation due to a potential shortage of raw ingredient. The letter describing this in detail is available at the following link: https://www.fresenius-kabi.com/us/news/fresenius-kabi-responds-to-a-potential-shortage-of-heparin.
    • Hikma did not provide a reason for the shortage.
    • Mylan refuses to provide updated availability information.
    • Pfizer has heparin on shortage due to manufacturing delays.
    • Sagent has heparin on shortage due to manufacturing issues and increased demand.

Available Products

    • Heparin Sodium solution for injection, BBraun, 5,000 unit/mL, 0.5 mL prefilled syringe, 10 count, NDC 00264-5705-10
    • Heparin Sodium solution for injection, Pfizer, 1,000 unit/mL, 1 mL single dose vial, 25 count, NDC 00409-2720-01
    • Heparin Sodium solution for injection, Pfizer, 5,000 unit/mL, 1 mL multiple dose vial, 25 count, NDC 00069-0059-03
    • Heparin Sodium solution for injection, Pfizer, 5,000 unit/mL, 10 mL multiple dose vial, 25 count, NDC 00069-0059-01
    • Heparin Sodium solution for injection, Sagent, 1,000 unit/mL, 30 mL multiple dose vial, 25 count, NDC 25021-0400-30

Estimated Resupply Dates

    • Fresenius Kabi has heparin 1,000 unit/mL 2 mL vials on back order and the company estimates a release date of early- to mid-July 2019. The 5,000 unit/mL 10 mL vials are on back order and the company estimates a release date of mid-August 2019. The 5,000 unit/mL 1 mL syringes are on back order and the company estimates a release date of early- to mid-July 2019. The 10,000 unit/mL 4 mL vials are on back order and the company cannot estimate a release date. There are short-dated 20,000 unit/mL 1 mL vials available with an expiration date of < 8 months. All other presentations are on allocation.
    • Hikma has 1,000 unit/mL 2 mL vials on back order and the company estimates a release date of early- to mid-July 2019. The 5,000 unit/mL 2 mL vials and 10,000 unit/mL 2 mL vials are on allocation.
    • Pfizer has 5,000 unit/mL 1 mL Carpuject syringes on back order and the company estimates a release date of July 2019. The 5,000 unit/mL 1 mL glass vials and 1,000 unit/mL 30 mL glass vials on back order and the company estimates a release date of August 2019. The 1,000 unit/mL 10 mL vials are on back order and the company estimates a release date of November 2019. The 10,000 unit/mL 0.5 mL Carpuject syringes and 1,000 unit/mL 10 mL vials are available in limited supply. The 5,000 unit/mL 10 mL vials are on back order and the company estimates a release date in December 2019.
    • Sagent has 1,000 unit/mL 1 mL, 2 mL, and 10 mL vials on back order and the company estimates a release date of July 2019. The 1,000 unit/mL 30 mL vials are on back order and the company estimates a release date of September 2019. The 5,000 unit/mL 1 mL and 10 mL vials are on back order and the company estimates a release date of July 2019. The 10,000 unit/mL 1 mL and 4 mL vials are on back order and the company estimates a release date of July 2019. There are short-dated 20,000 unit/mL 1 mL vials available with an expiration date of

Safety

    • Pfizer has sent a safety information letter about certain lots of heparin injection and other medications supplied in Carpuject syringes. There is a potential for particulates and cracked needle hubs.
    • Special instructions are described in this letter including doing visual inspection for cracks and particulate matter and using a 5 micron filter for administration. The details of the special handling instructions and affected lot numbers are available at https://www.pfizerinjectablessupply.com/sites/default/files/carpuject_specific_lot_handling_instructions.pdf.

Updated

Updated July 10, 2019 by Michelle Wheeler, PharmD, Drug Information Specialist. Created October 13, 2017 by Leslie Jensen, 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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