FDA Drug Shortages

Current and Resolved Drug Shortages and Discontinuations Reported to FDA

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Sodium Chloride 0.9% Injection Bags
Status: Currently in Shortage
»Date first posted: 01/15/2014
»Therapeutic Categories: Gastroenterology; Other; Pediatric

For detailed clinical recommendations to use during this shortage, please see information posted by the American Society of Health-System Pharmacists.
Small-Volume Parenteral Solutions Shortages, Suggestions for Management and Conservation

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B. Braun Medical Inc. (Revised 11/02/2017)

Company Contact Information:
800-227-2862

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
0.9% NaCl 250mL bag, PVC/DEHP-free (NDC 00264-7800-20) Product on allocation, estimated recovery Q1 2018

BBraun Customer Letter IV Solution Shortage

Manufacturing interruptions and demand increase
0.9% NaCl 500mL bag, PVC/DEHP-free (NDC 00264-7800-10) Product on allocation, estimated recovery Q1 2018

BBraun Customer Letter IV Solution Shortage

Manufacturing interruptions and demand increase
0.9% NaCl 1000mL bag, PVC/DEHP-free (NDC 00264-7800-00) Product on allocation, estimated recovery Q1 2018

BBraun Customer Letter IV Solution Shortage

Manufacturing interruptions and demand increase
0.9% Sodium Chloride Injection USP 100mL fill in 150mL PAB S8004-5264 (NDC 0264-1800-32) Product on allocation. Estimated recovery: Q1 2018

BBraun Customer Letter IV Solution Shortage

Manufacturing interruptions and demand increase
0.9% Sodium Chloride Injection USP 50mL fill in 100mL PAB S8004-5384 (NDC 0264-1800-31) Product on allocation. Estimated recovery: Q1 2018

BBraun Customer Letter IV Solution Shortage

Manufacturing interruptions and demand increase
0.9% Sodium Chloride Injection USP 25mL fill in 100mL PAB S8004-5410 (NDC 0264-1800-36) Product on allocation. Estimated recovery: Q1 2018

BBraun Customer Letter IV Solution Shortage

Manufacturing interruptions and demand increase
Sodium Chloride 0.9% w/v Intravenous Infusion BP in the Ecoflac® plus container sizes: 500 mL (NDC 0264-9999-10) Available B. Braun Medical Inc. in conjunction with FDA has initiated temporary importation of Sodium Chloride 0.9% w/v Intravenous Infusion BP in the Ecoflac® plus container into the U.S. market to address drug shortage. Importation will begin mid October 2014. Limited quantities available from B. Braun or authorized distributors. All orders must be placed with B. Braun Medical Inc Customer Service at 1-800-227-2862. Please see Dear Health Care Provider Letter (PDF).

Dear Health Care Provider Letter


Useful Handling Tips for Ecloflac plus
Useful Handling Tips for Ecloflac plus - Infusion Administration
Available

Baxter Healthcare (Revised 10/25/2017)

Company Contact Information:
888-229-0001

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
0.9% Sodium Chloride Injection, USP, 100 mL VIAFLEX Plastic Container. Single pack (NDC 0338-0049-48) Quad Pack (NDC 0338-0049-18) Multi Pack (NDC 0338-0049-38) On allocation Other
0.9% Sodium Chloride Injection, USP, 50 mL VIAFLEX Plastic Container. Single Pack (NDC 0338-0049-41) Quad Pack (NDC 0338-0049-11) Multi Pack (NDC 0338-0049-31) On allocation Other
0.9% Sodium Chloride Injection, USP, 25 mL VIAFLEX Plastic Container Quad Pack (NDC 0338-0049-10) On allocation Other
Sodium Chloride 0.9% Intravenous Infusion, 100 mL, in VIAFLEX Container Product code AHB1307 (NDC 0338-9563-48) Limited quantities will be available in the next few weeks. Baxter will provide further updates as more product becomes available. Baxter Healthcare Corporation in conjunction with FDA has initiated temporary importation of Sodium Chloride 0.9% Intravenous Infusion in VIAFLEX Container into the U.S. market to address drug shortages.

Dear Health Care Provider Letter, Australia

Other
Sodium Chloride 0.9% Intravenous Infusion, 50 mL, in VIAFLEX Container Product code AHB1306A (NDC 0338-9567-60) Limited quantities will be available in the next few weeks. Baxter will provide further updates as more product becomes available. Baxter Healthcare Corporation in conjunction with FDA has initiated temporary importation of Sodium Chloride 0.9% Intravenous Infusion in VIAFLEX Container into the U.S. market to address drug shortages.

Dear Health Care Provider Letter, Australia

Other
Sodium Chloride 0.9% w/v Intravenous Infusion, BP, 50 mL, MINI-BAG Plus container, VIAFLEX plastic container Product code FPB0042G (NDC 0338-9613-30) Limited quantities will be available in the next few weeks. Baxter will provide further updates as more product becomes available. Baxter Healthcare Corporation in conjunction with FDA has initiated temporary importation of Sodium Chloride 0.9% w/v Intravenous Infusion BP in MINI-BAG Plus container in VIAFLEX (PVC) plastic container into the U.S. market to address drug shortages.

Dear Health Care Provider Letter, Ireland

Other
0.9% Sodium Chloride Injection, USP, 50 mL MINI-BAG Plus Container, VIAFLEX Plastic Container (NDC 0338-0553-11) On allocation Other
Sodium Chloride 0.9% w/v Intravenous Infusion, BP, 100 mL, MINI-BAG Plus in VIAFLEX plastic container, Product code FPB0043G (NDC 0338-9616-30) Limited quantities will be available in the next few weeks. Baxter will provide further updates as more product becomes available. Baxter Healthcare Corporation in conjunction with FDA has initiated temporary importation of Sodium Chloride 0.9% w/v Intravenous Infusion BP in MINI-BAG Plus container in VIAFLEX (PVC) plastic container into the U.S. market to address drug shortages.

Dear Health Care Letter, Ireland

Other
0.9% Sodium Chloride Injection, USP, 100 mL MINI-BAG Plus Container, VIAFLEX Plastic Container (NDC 0338-0553-18) On allocation Other
0.9% Sodium Chloride in Water for Injection, 50 mL, in VIAFLEX Container Product code ABB1306U (NDC 0338-9520-11) Limited quantities will be available in the next few weeks. Baxter will provide further updates as more product becomes available. Baxter Healthcare Corporation in conjunction with FDA has initiated temporary importation of 0.9% Sodium Chloride in Water for Injection in VIAFLEX Container into the U.S. market to address drug shortages.

Dear Health Care Letter, Mexico

Other
0.9% Sodium Chloride in Waiter for Injection, 100 mL, in VIAFLEX Container Product code ABB1307U (NDC 0338-9525-72) Limited quantities will be available in the next few weeks. Baxter will provide further updates as more product becomes available. Baxter Healthcare Corporation in conjunction with FDA has initiated temporary importation of 0.9% Sodium Chloride Injection in VIAFLEX Container into the U.S. market to address drug shortages.

Dear Health Care Letter, Mexico

Other
0.9% Sodium Chloride Injection, USP, 50 mL, in VIAFLEX Container Product code JB1301P (NDC 0338-9579-96) Limited quantities will be available in the next few weeks. Baxter will provide further updates as more product becomes available. Baxter Healthcare Corporation in conjunction with FDA has initiated temporary importation of 0.9% Sodium Chloride Injection, USP, in VIAFLEX Container into the U.S. market to address drug shortages.

Dear Health Care Letter, Canada

Other
0.9% Sodium Chloride Injection, USP, 100 mL, in VIAFLEX Container Product code JB1302P (NDC 0338-9583-96) Limited quantities will be available in the next few weeks. Baxter will provide further updates as more product becomes available. Baxter Healthcare Corporation in conjunction with FDA has initiated temporary importation of 0.9% Sodium Chloride Injection, USP, in VIAFLEX Container into the U.S. market to address drug shortages.

Dear Health Care Letter, Canada

Other
0.9% Sodium Chloride Injection, USP, 50 mL, in MINI-BAG Plus Container, Product code JB0042 (NDC 0338-9531-96) Limited quantities will be available in the next few weeks. Baxter will provide further updates as more product becomes available. Baxter Healthcare Corporation in conjunction with FDA has initiated temporary importation of 0.9% Sodium Chloride Injection USP in MINI-BAG Plus container, VIAFLEX (PVC) plastic container into the U.S. market to address drug shortages.

Dear Health Care Letter, Canada

Other
0.9% Sodium Chloride Injection, USP, 100 mL, in MINI-BAG Plus Container, VIAFLEX Plastic Container. Product code JB0043P (NDC 0338-9535-72) Limited quantities will be available in the next few weeks. Baxter will provide further updates as more product becomes available. Baxter Healthcare Corporation in conjunction with FDA has initiated temporary importation of 0.9% Sodium Chloride Injection, USP, MINI-BAG Plus Container, VIAFLEX plastic container into the U.S. market to address drug shortages.

Dear Health Care Letter, Canada

Other
0.9% Sodium Chloride Injection, USP, 250 mL. Product code JB1322P (NDC 00338-9604-30) Limited quantities will be available in the next few weeks. Baxter will provide further updates as more product becomes available. Baxter Healthcare Corporation in conjunction with FDA has initiated temporary importation of 0.9% Sodium Chloride Injection, USP, in VIAFLEX Container into the U.S. market to address drug shortages.

Dear Health Care Letter, Canada

Other
0.9% Sodium Chloride Injection, USP, 500 mL. Product code JB1323 (NDC 00338-9608-24) Limited quantities will be available in the next few weeks. Baxter will provide further updates as more product becomes available. Baxter Healthcare Corporation in conjunction with FDA has initiated temporary importation of 0.9% Sodium Chloride Injection, USP, in VIAFLEX Container into the U.S. market to address drug shortages.

Dear Health Care Letter, Canada

Other
0.9% Sodium Chloride Injection, USP, 1000 mL. Product code JB1324 (NDC 00338-9612-12) Limited quantities will be available in the next few weeks. Baxter will provide further updates as more product becomes available. Baxter Healthcare Corporation in conjunction with FDA has initiated temporary importation of 0.9% Sodium Chloride Injection, USP, in VIAFLEX Container into the U.S. market to address drug shortages.

Dear Health Care Letter, Canada

Other

Fresenius Kabi USA, LLC (Revised 11/17/2017)

Company Contact Information:
888-386-1300

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
Sodium Chloride Injection USP, 0.9%, 50mL (NDC 63323-623-53) Limited availability anticipated January 2018 Increase in demand
Sodium Chloride Injection USP, 0.9%, 100mL (NDC 63323-623-61) Limited availability anticipated December 2017 Increase in demand
Sodium Chloride Injection USP, 0.9%, 250mL (NDC 63323-623-74) Release anticipated Q1 2018 Increase in demand
Sodium Chloride Injection USP, 0.9%, 500mL (NDC 63323-623-75) Limited availability anticipated December 2017 Increase in demand
Sodium Chloride Injection USP, 0.9%, 1000mL (NDC 63323-623-76) Limited availability anticipated December 2017 Increase in demand

Fresenius Medical Care North America (Revised 10/27/2017)

Company Contact Information:
800-323-5188

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
1000ml (NDC 49230-300-10) Fresenius has this product on allocation Demand increase for the drug

Hospira, Inc. (Revised 11/13/2017)

Company Contact Information:
844-646-4398

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
0.9%; 50 mL (5-Pack) ADD-Vantage™ Flexible Container (NDC 0409-7101-66) Next delivery: Early November 2017; Estimated recovery: June 2018 Please check with your wholesaler for available inventory. Demand increase for the drug
0.9%; 100 mL (5-Pack) ADD-Vantage™ Flexible Container (NDC 0409-7101-67) Next delivery: Early December 2017; Estimated recovery: June 2018 Please check with your wholesaler for available inventory. Demand increase for the drug
0.9%; 250 mL (Dual Pack) ADD-Vantage™ Flexible Container (NDC 0409-7101-02) Next delivery: Mid November 2017; Estimated recovery: June 2018 Please check with your wholesaler for available inventory. Demand increase for the drug

ICU Medical, Inc. (Revised 11/21/2017)

Company Contact Information:
877-946-7747

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
50 mL flexible container (NDC 0409-7984-13) Next delivery and estimated recovery: Mid-December 2017 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
100 mL flexible container (NDC 0409-7984-23) Next delivery and estimated recovery: Late November 2017 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
100 mL flexible container-4 pack (NDC 0409-7984-37) Next delivery: Mid-November 2017. Estimated recovery: Early December 2017 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
150mL flexible container (NDC 0409-7983-61) Next delivery & Estimated Recovery: Mid-November 2017 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
250mL Vis-IV container, PVC/DEHP-free (NDC 0409-7983-25) Next delivery: Late November 2017. Estimated recovery: Early January 2018 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
250mL flexible container (NDC 0409-7983-02) Next delivery: Late November 2017. Estimated Recovery: Late February 2018 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
250mL flexible container 2 port (NDC 0409-7983-53) Next delivery: Late November 2017. Estimated recovery: Late December 2017 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
500mL flexible container 2 port (NDC 0409-7983-55) 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
500mL flexible container (NDC 0409-7983-03) 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
1000mL flexible container (NDC 0409-7983-09) 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

Laboratorios Grifols, S.A. (Revised 10/02/2017)

Company Contact Information:
800-848-0462

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
0.9% Sodium Chloride Injection, USP 500 mL Fleboflex Plastic Container (20 units/carton)(NDC NDC 67457-704-50) Estimated availability: TBD Manufacturer: Laboratorios Grifols, S.A.; Distributor: Mylan Institutional LLC Mylan Customer Service Number: 1.800.848.0462 Other

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