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: No date available
»Therapeutic Categories: Gastroenterology; Other; Pediatric

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

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 to contracted customers

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 to contracted customers

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 to contracted customers

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 to contracted customers

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 to contracted customers

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 to contracted customers

BBraun Customer Letter IV Solution Shortage

Manufacturing interruptions and demand increase
Sodium Chloride 0.9% w/v Intravenous Infusion BP in the Ecoflac® plus 1,000 mL Product Code 9999-00, (NDC 0264-9999-00) Available

Dear Health Care Provider Letter


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

Baxter Healthcare (Revised 07/26/2018)

Company Contact Information:
888-229-0001

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
0.9% Sodium Chloride Injection, 100 mL, in VIAFLEX Container. Product code FZB1307 (NDC 0338-9517-72) Available Baxter Healthcare Corporation in conjunction with FDA has initiated temporary importation of Sodium Chloride 0.9% Injection in VIAFLEX Container into the U.S. market to address drug shortages.

Dear Health Care Letter, Brazil

Other
0.9% Sodium Chloride Injection, 250 mL, in VIAFLEX Container. Product code FZB1322 (NDC 0338-9517-50) Available Baxter Healthcare Corporation in conjunction with FDA has initiated temporary importation of Sodium Chloride 0.9% Injection in VIAFLEX Container into the U.S. market to address drug shortages.

Dear Health Care Letter, Brazil

Other
0.9% Sodium Chloride Injection, 500 mL, in VIAFLEX Container. Product code FZB1323 (NDC 0338-9517-30) Available Baxter Healthcare Corporation in conjunction with FDA has initiated temporary importation of Sodium Chloride 0.9% Injection in VIAFLEX Container into the U.S. market to address drug shortages.

Dear Health Care Letter, Brazil

Other
0.9% Sodium Chloride Injection, 1,000 mL, in VIAFLEX Container. Product code FZB1324 (NDC 0338-9517-16) Available Baxter Healthcare Corporation in conjunction with FDA has initiated temporary importation of Sodium Chloride 0.9% Injection in VIAFLEX Container into the U.S. market to address drug shortages.

Dear Health Care Letter, Brazil

Other
150 mL (NDC 00338-0049-01) Unavailable Demand increase for the drug
250 mL Product code 2B1322Q (NDC 00338-0049-02) On allocation Other
250 mL PVC/DEHP-free AVIVA container (NDC 0338-6304-02) Available as NDC 0338-9543-02 (VIAFLO container). On allocation. Other
500 mL Product code 2B1323Q (NDC 00338-0049-03) On allocation Other
500 mL Non-PVC, Dripless Access Container (DAC) VIAFLO Container Product code UE1323D (NDC 0338-9543-04) On allocation Other
1000 mL Product code 2B1324X (NDC 00338-0049-04) On allocation Demand increase for the drug
1000 mL Non-PVC, Dripless Access Container (DAC) VIAFLO Container Product code UE1324D (NDC 0338-9543-06) On allocation Other
250 mL, Non-PVC, Dripless Access Container (DAC) VIAFLO Container Product code UE1322D (NDC 0338-9543-02) On allocation Other
500 mL PVC/DEHP-free AVIVA container (NDC 0338-6304-03) Available as NDC 0338-9543-04 (VIAFLO container). On allocation. Other
0.9% Sodium Chloride Injection, USP, 100 mL VIAFLEX Plastic Container. Single pack (NDC 0338-0049-48, product code 2B1307)Quad Pack (NDC 0338-0049-18, product code 2B1302) Multi Pack (NDC 0338-0049-38, product code 2B1309) On allocation Other
0.9% Sodium Chloride Injection, USP, 50 mL VIAFLEX Plastic Container. Single Pack (NDC 0338-0049-41, product code 2B1306) Quad Pack (NDC 0338-0049-11, product code 2B1301) Multi Pack (NDC 0338-0049-31, product code 2B1308) On allocation Other
0.9% Sodium Chloride Injection, USP, 25 mL VIAFLEX Plastic Container Quad Pack (NDC 0338-0049-10). Product code 2B1300 On allocation Other
Sodium Chloride 0.9% Intravenous Infusion, 100 mL, in VIAFLEX Container Product code AHB1307 (NDC 0338-9563-48) 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) Unavailable 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) Unavailable 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 Product code 2B0042 (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) 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 Product code 2B0043 (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) Unavailable 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) 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) Unavailable 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) Unavailable 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) Unavailable 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) Unavailable 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) Unavailable 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) 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) 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 07/26/2018)

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 quantity release anticipated March 2018. Increase in demand
Sodium Chloride Injection USP, 0.9%, 100mL (NDC 63323-623-61) Limited inventory available. Increase in demand
Sodium Chloride Injection USP, 0.9%, 250mL (NDC 63323-623-74) Limited inventory available. Increase in demand
Sodium Chloride Injection USP, 0.9%, 500mL (NDC 63323-623-75) Available for direct orders. Increase in demand
Sodium Chloride Injection USP, 0.9%, 1000mL (NDC 63323-623-76) Available for direct orders. 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 08/08/2018)

Company Contact Information:
844-646-4398

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
50 mL (5-Pack); ADD-Vantage Flexible Container (NDC 00409-7101-66) Limited Supply Available. Next Delivery: August 2018; Estimated Recovery: 2019 Demand increase for the drug
100 mL (5-Pack); ADD-Vantage Flexible Container (NDC 00409-7101-67) Limited Supply Available. Next Delivery: August 2018; Estimated Recovery: 2019 Demand increase for the drug
250 mL (Dual Pack); ADD-Vantage Flexible Container (NDC 00409-7101-02) Limited Supply Available. Next Delivery: August 2018; Estimated Recovery: 2019 Demand increase for the drug

ICU Medical, Inc. (Revised 08/09/2018)

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: Late Sept Estimated recovery: Early October 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
100 mL flexible container (NDC 0409-7984-23) Next delivery: Early September Estimated recovery: Mid September 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 September Estimated recovery: Early October 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: Mid August Estimated recovery: Late September 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) Product on allocation to contracted customers 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
250mL flexible container (NDC 0409-7983-02) Next delivery: Mid August Estimated recovery: Mid Aug 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) 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
500mL flexible container 2 port (NDC 0409-7983-55) 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
500mL flexible container (NDC 0409-7983-03) 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
1000mL flexible container (NDC 0409-7983-09) 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

Laboratorios Grifols, S.A. (Revised 03/01/2018)

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 76297-001-01) Estimated availability: March 2018 Manufacturer: Laboratorios Grifols, S.A.; Distributor: Henry Schein 1-866-248-9907

Dear Customer Letter

Other

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