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 10/02/2018)

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) Available Currently releasing product Other
10 mL vial (NDC 00517-3010-25) Available Currently releasing product Other
20 mL vial (NDC 00517-3020-25) Unavailable Currently not releasing product Other

B. Braun Medical Inc. (Revised 07/24/2018)

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 Manufacturing interruptions and demand increase
Sterile Water for Injection in 1,000mL EXCEL container (NDC 0264-7850-00) Product on allocation to contracted customers Manufacturing interruptions and demand increase
Sterile Water for Injection in 2,000mL Titan container (NDC 0264-7385-50) Product on allocation to contracted customers Manufacturing interruptions and demand increase
Sterile Water for Injection in 3,000mL Titan container (NDC 0264-7385-60) Product on allocation to contracted customers Manufacturing interruptions and demand increase
Sterile Water for Injection in 250mL EXCEL container (NDC 0264-7850-20) Product on allocation to contracted customers Manufacturing interruptions and demand increase

Baxter Healthcare (Reverified 08/29/2018)

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

Fresenius Kabi USA, LLC (Revised 10/15/2018)

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. Check wholesaler inventory Increased demand
Single dose, plastic vial, 10 mL fill (NDC 63323-185-10) Available Check wholesaler inventory Increased demand
Single dose, plastic vial, 20 mL fill (NDC 63323-185-20) Available Check wholesaler inventory Increased demand
Single dose, plastic vial, 50 mL fill (NDC 63323-185-50) Backordered. Ongoing intermittent releases - next release November 2018. Increased demand
Single dose, tear top vial, 100 mL (NDC 63323-185-00) Backordered. Ongoing intermittent releases - next release not available at this time. Check wholesaler inventory 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 10/11/2018)

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) Available Other
20 mL; Single Dose Plastic Fliptop Vial (NDC 00409-4887-20) Next Delivery: October 2018; Estimated Recovery: March 2019 Demand increase for the drug
50 mL; Single Dose Plastic Fliptop Vial (NDC 00409-4887-50) Next Delivery: November 2018; Estimated Recovery: March 2019 Demand increase for the drug
100 mL; Single Dose Glass Fliptop Vial (NDC 00409-4887-99) Next Delivery: November 2018; Estimated Recovery: December 2018 Demand increase for the drug

ICU Medical, Inc. (Revised 10/03/2018)

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) Next delivery: Mid October Estimated recovery: Late November Shortage per manufacturer: Manufacturing Delay. 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) 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

West-Ward Pharmaceuticals (Reverified 09/10/2018)

Company Contact Information:
800-631-2174

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
10 mL Single Dose Vial (NDC 0641-6147-25) Inventory is currently available. Product is being introduced to the market the week of August 6, 2018. Additional lots are scheduled to be manufactured. Product will be made available as it is released. Demand increase for the drug

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