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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American Regent/Luitpold (Reverified 07/09/2018)

Company Contact Information:
800-645-1706

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
5 mL vial (NDC 00517-3005-25) Unavailable Currently not releasing product Other
10 mL vial (NDC 00517-3010-25) Unavailable Currently not releasing product Other
20 mL vial (NDC 00517-3020-25) Unavailable Currently not releasing product Other

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 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
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

Baxter Healthcare (Reverified 07/13/2018)

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. Product code 2B0304X (NDC 0338-0013-04) On allocation Increased demand
Sterile Water for Injection, USP in 2000 mL VIAFLEX Plastic Container. Pharmacy Bulk Package. Product code 2B0306 (NDC 0338-0013-06) On allocation Increased demand
Sterile Water for Injection, USP in 3000 mL VIAFLEX Plastic Container. Pharmacy Bulk Package. Product code 2B0307 (NDC 0338-0013-08) On allocation Increased demand
Sterile Water for Injection, USP in 5000 mL VIAFLEX Plastic Container, Pharmacy Bulk Package. Product code 2B0309 (NDC 0338-0013-29) On allocation Increased demand

Fresenius Kabi USA, LLC (Revised 06/26/2018)

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) Backordered. Ongoing intermittent releases - next release anticipated August 2018. 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 August 2018. Check wholesaler inventory Increased demand
Single dose, plastic vial, 20 mL fill (NDC 63323-185-20) Backordered. Ongoing intermittent releases - next release anticipated August 2018. Check wholesaler inventory Increased demand
Single dose, plastic vial, 50 mL fill (NDC 63323-185-50) Backordered. Ongoing intermittent releases - next release anticipated August 2018. Increased demand
Single dose, tear top vial, 100 mL (NDC 63323-185-00) Backordered. Ongoing intermittent releases - next release anticipated July 2018. Increased demand

Genentech, Inc (New 05/14/2018)

Company Contact Information:
800-551-2231

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
Sterile Water for Injection in 5 mL glass ampules (NDC 50242-001-05) Available (Product on allocation) Genentech in conjunction with FDA has initiated temporary importation of Sterile Water for Injection into the U.S. market to address drug shortage. Please see the Dear Health Care Provider Letter

Dear Health Care Provider Letter

Other

Hospira, Inc. (Revised 07/20/2018)

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) Next Delivery: July 2018; Estimated Recovery: September 2018 Demand increase for the drug
20 mL; Single Dose Plastic Fliptop Vial (NDC 00409-4887-20) Next Delivery: July 2018; Estimated Recovery: December 2018 Demand increase for the drug
50 mL; Single Dose Plastic Fliptop Vial (NDC 00409-4887-50) Next Delivery: August 2018; Estimated Recovery: October 2018 Demand increase for the drug
100 mL; Single Dose Glass Fliptop Vial (NDC 00409-4887-99) Next Delivery: July 2018; Estimated Recovery: September 2018 Demand increase for the drug

ICU Medical, Inc. (Revised 06/25/2018)

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) Product on allocation 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) Product on allocation 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) Product on allocation 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) Product on allocation 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) Product on allocation 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) Product on allocation 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) Product on allocation 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) Product on allocation 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) Product on allocation 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

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