FDA Drug Shortages

Current and Resolved Drug Shortages and Discontinuations Reported to FDA

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Sterile Water
Status: Currently in Shortage
»Date first posted: 01/22/2018
»Therapeutic Categories: Other

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B. Braun Medical Inc. (Reverified 03/16/2018)

Company Contact Information:
800-227-2862

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
Sterile Water for Injection in 250mL EXCEL container (NDC 0264-7850-20) Product on allocation to contracted customers, on intermittent back-order with anticipated resolution by end March 2018 Manufacturing interruptions and demand increase
Sterile Water for Injection in 500mL EXCEL container (NDC 0264-7850-10) Product on allocation to contracted customers, on intermittent back-order with anticipated resolution by end March 2018 Manufacturing interruptions and demand increase
Sterile Water for Injection in 1,000mL EXCEL container (NDC 0264-7850-00) Product on allocation to contracted customers, on intermittent back-order with anticipated resolution by end March 2018 Manufacturing interruptions and demand increase
Sterile Water for Injection in 2,000mL Titan container (NDC 0264-7385-50) Product on allocation to contracted customers, on intermittent back-order with anticipated resolution by end March 2018 Manufacturing interruptions and demand increase
Sterile Water for Injection in 3,000mL Titan container (NDC 0264-7385-60) Product on allocation to contracted customers, on intermittent back-order with anticipated resolution by end March 2018 Manufacturing interruptions and demand increase

Baxter Healthcare (Reverified 03/21/2018)

Company Contact Information:
888-229-0001

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
Sterile Water for Injection, USP (For Drug Diluent Use Only), 1000 mL VIAFLEX Plastic Container (NDC 0338-0013-04) On allocation for existing customers only. Backordered until March 2018 Increased demand
Sterile Water for Injection, USP in 2000 mL VIAFLEX Plastic Container. Pharmacy Bulk Package (NDC 0338-0013-06) On allocation for existing customers only. Increased demand
Sterile Water for Injection, USP in 3000 mL VIAFLEX Plastic Container. Pharmacy Bulk Package (NDC 0338-0013-08) On allocation for existing customers only. Increased demand
Sterile Water for Injection, USP in 5000 mL VIAFLEX Plastic Container, Pharmacy Bulk Package (NDC 0338-0013-29) On allocation for existing customers only. Increased demand

Fresenius Kabi USA, LLC (Revised 04/03/2018)

Company Contact Information:
888-386-1300

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
Single dose vial, 5 mL fill (NDC 63323-185-05) Available All Sterile Water presentations are on intermittent back order and will be released as the product becomes available. Increased demand
Single dose, plastic vial, 10 mL fill (NDC 63323-185-10) Backordered. Ongoing intermittent releases - next release anticipated April 2018. Check wholesaler inventory Increased demand
Single dose, plastic vial, 20 mL fill (NDC 63323-185-20) Backordered. Ongoing intermittent releases - next release anticipated May 2018. Check wholesaler inventory Increased demand
Single dose, plastic vial, 50 mL fill (NDC 63323-185-50) Backordered. Ongoing intermittent releases - next release anticipated April 2018. Increased demand
Single dose, tear top vial, 100 mL (NDC 63323-185-00) Backordered. Ongoing intermittent releases - next release anticipated May 2018. Increased demand

Hospira, Inc. (Revised 04/13/2018)

Company Contact Information:
844-646-4398

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
10 mL Single Dose Plastic Fliptop Vial (NDC 00409-4887-10) Limited Supply Available. Next Delivery: Late April 2018; Estimated recovery: September 2018 Shortage per Manufacturer: Manufacturing Delay Other
20 mL Single Dose Plastic Fliptop Vial (NDC 00409-4887-20) Limited Supply Available. Next Delivery: Early July 2018; Estimated recovery: September 2018 Shortage per Manufacturer: Manufacturing Delay Other
50 mL Single Dose Plastic Fliptop Vial (NDC 00409-4887-50) Next Delivery: Early May 2018; Estimated recovery: June 2018 Shortage per Manufacturer: Manufacturing Delay Other
100 mL Single Dose Plastic Fliptop Vial (NDC 00409-4887-99) Limited Supply Available. Next Delivery: Late April 2018; Estimated recovery:September 2018 Shortage per Manufacturer: Manufacturing Delay Other

ICU Medical, Inc. (Revised 04/17/2018)

Company Contact Information:
877-946-7747

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
Sterile Water for Injection 2000 mL (NDC 0409-7118-07) Available Available. ICU Medical acquired these products from Hospira, a Pfizer company. For questions or inquiries regarding these Hospira labeled products, please contact ICU Medical. Other
Sterile Water for Irrigation 1000 mL (NDC 0409-7973-05) Available Available. ICU Medical acquired these products from Hospira, a Pfizer company. For questions or inquiries regarding these Hospira labeled products, please contact ICU Medical. Other
Sterile Water for Irrigation 2000 mL (NDC 0409-7973-08) Available Available. ICU Medical acquired these products from Hospira, a Pfizer company. For questions or inquiries regarding these Hospira labeled products, please contact ICU Medical. Other
Sterile Water for Irrigation 2000 mL (NDC 0409-7973-07) Available Available. ICU Medical acquired these products from Hospira, a Pfizer company. For questions or inquiries regarding these Hospira labeled products, please contact ICU Medical. Other
Sterile Water for Irrigation USP, 1000 mL Aqualite ™ Plastic Pour Bottle (NDC 0409-7139-09) Available Available. ICU Medical acquired these products from Hospira, a Pfizer company. For questions or inquiries regarding these Hospira labeled products, please contact ICU Medical. Other
Sterile Water for Irrigation, USP, Aqualite 500 mL (NDC 0409-6139-03) Available Available. ICU Medical acquired these products from Hospira, a Pfizer company. For questions or inquiries regarding these Hospira labeled products, please contact ICU Medical. Other
Sterile Water for Irrigation, USP 1500 mL (NDC 0409-7139-36) Available Available. ICU Medical acquired these products from Hospira, a Pfizer company. For questions or inquiries regarding these Hospira labeled products, please contact ICU Medical. Other
Sterile Water for Irrigation, USP, Aqualite 250 mL (NDC 0409-6139-22) Available Available. ICU Medical acquired these products from Hospira, a Pfizer company. For questions or inquiries regarding these Hospira labeled products, please contact ICU Medical. Other
Sterile Water for Injection 1000 mL (NDC 0409-7990-09) Next delivery and estimated recovery: Late April Please check with your wholesaler for available inventory. ICU Medical acquired these products from Hospira, a Pfizer company. For questions or inquiries regarding these Hospira labeled products, please contact ICU Medical. Demand increase for the drug

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