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.
Intravenous Solution Conservation Strategies (ASHP) (PDF)

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B. Braun Medical Inc. (Revised 05/24/2016)

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) Available for current customers. Demand increase for the drug
0.9% NaCl 500mL bag, PVC/DEHP-free (NDC 00264-7800-10) Available for current customers. Demand increase for the drug
0.9% NaCl 1000mL bag, PVC/DEHP-free (NDC 00264-7800-00) Available for current customers. Demand increase for the drug
Sodium Chloride 0.9% w/v Intravenous Infusion BP in the EcoflacĀ® 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 EcoflacĀ® 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 (Reverified 11/29/2016)

Company Contact Information:
888-229-0001

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
250 mL, Non-PVC, Dripless Access Container (DAC) VIAFLO Container (NDC 0338-9543-02) Available Other
500 mL PVC/DEHP-free AVIVA container (NDC 0338-6304-03) Available as NDC 0338-9543-04 (VIAFLO container) Other
150 mL (NDC 00338-0049-01) Unavailable. Production is planned to resume in 2017. Demand increase for the drug
250 mL (NDC 00338-0049-02) Available Other
250 mL PVC/DEHP-free AVIVA container (NDC 0338-6304-02) Available as NDC 0338-9543-02 (VIAFLO container) Other
500 mL (NDC 00338-0049-03) Available Other
500 mL Non-PVC, Dripless Access Container (DAC) VIAFLO Container (NDC 0338-9543-04) Available Other
1000 mL (NDC 00338-0049-04) Available for current customers. Demand increase for the drug
1000 mL Non-PVC, Dripless Access Container (DAC) VIAFLO Container (NDC 0338-9543-06) Available Other

Fresenius Kabi USA, LLC (Reverified 11/30/2016)

Company Contact Information:
888-386-1300

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
0.9% Freeflex Injection Solution for Intravenous Infusion (Australian label / English) 100 mL (NDC 63323-623-00) No further 100 mL will be available. Please check wholesaler inventory. Fresenius Kabi USA, LLC in conjunction with FDA has initiated temporary importation of Sodium Chloride 0.9% Freeflex Injection Solution into the U.S. market to address this shortage. Importation began March 2014. No remaining quantities available direct through Fresenius Kabi - please check wholesaler inventory.

Please see the Dear Healthcare Professional Letter for additional product and supply information.


Also attached is the Package Insert for product information. All orders must be placed with Fresenius Kabi Customer Service Department by calling 1-888-386-1300.
Please see DHCP letter on Importation of European Drug Product
Other
0.9% Freeflex Injection Solution for Intravenous Infusion (Australian label / English) 500 mL (NDC 63323-623-59) No further 500 mL will be available. Please check wholesaler inventory. Fresenius Kabi USA, LLC in conjunction with FDA has initiated temporary importation of Sodium Chloride 0.9% Freeflex Injection Solution into the U.S. market to address this shortage. Importation began March 2014. No remaining quantities available direct through Fresenius Kabi - please check wholesaler inventory.

Please see the Dear Healthcare Professional Letter for additional product and supply information.


Also attached is the Package Insert for product information. All orders must be placed with Fresenius Kabi Customer Service Department by calling 1-888-386-1300.
Please see DHCP letter on Importation of European Drug Product
Other
0.9% Freeflex Injection Solution for Intravenous Infusion (Australian label / English) 1000 mL (NDC 63323-623-10) No further 1000 mL will be available. Please check wholesaler inventory. Fresenius Kabi USA, LLC in conjunction with FDA has initiated temporary importation of Sodium Chloride 0.9% Freeflex Injection Solution into the U.S. market to address this shortage. Importation began March 2014. No remaining quantities available direct through Fresenius Kabi - please check wholesaler inventory.

Please see the Dear Healthcare Professional Letter for additional product and supply information.


Also attached is the Package Insert for product information. All orders must be placed with Fresenius Kabi Customer Service Department by calling 1-888-386-1300.
Please see DHCP letter on Importation of European Drug Product
Other
0.9% Freeflex Injection Solution for Intravenous Infusion (Scandinavian label) freeflex container: 50 mL (NDC 63323-623-57) No further Scandinavian inventory available. Fresenius Kabi USA, LLC in conjunction with FDA has initiated temporary importation of Sodium Chloride 0.9% Freeflex Injection Solution into the U.S. market to address this shortage.

Please see the Dear Healthcare Professional Letter for additional product and supply information.


Also attached is the Package Insert for product information. All orders must be placed with Fresenius Kabi Customer Service Department by calling 1-888-386-1300.
Please see DHCP letter on Importation of European Drug Product
Other
0.9% Freeflex Injection Solution for Intravenous Infusion (Scandinavian label) freeflex container: 100 mL (NDC 63323-623-09) No further Scandinavian inventory available. Fresenius Kabi USA, LLC in conjunction with FDA has initiated temporary importation of Sodium Chloride 0.9% Freeflex Injection Solution into the U.S. market to address this shortage.

Please see the Dear Healthcare Professional Letter for additional product and supply information.


Also attached is the Package Insert for product information. All orders must be placed with Fresenius Kabi Customer Service Department by calling 1-888-386-1300.
Other
0.9% Freeflex Injection Solution for Intravenous Infusion (Scandinavian label) freeflex container: 500 mL (NDC 63323-623-51) No further Scandinavian inventory available. Fresenius Kabi USA, LLC in conjunction with FDA has initiated temporary importation of Sodium Chloride 0.9% Freeflex Injection Solution into the U.S. market to address this shortage.

Please see the Dear Healthcare Professional Letter for additional product and supply information.


Also attached is the Package Insert for product information. All orders must be placed with Fresenius Kabi Customer Service Department by calling 1-888-386-1300.
Other
0.9% Freeflex Injection Solution for Intravenous Infusion (Australian label / English) 50 mL (NDC 63323-623-50) No further 50 mL will be available. Please check wholesaler inventory. Importation began March 2014. No remaining quantities available direct through Fresenius Kabi - please check wholesaler inventory.

Please see the Dear Healthcare Professional Letter for additional product and supply information.


Also attached is the Package Insert for product information. All orders must be placed with Fresenius Kabi Customer Service Department by calling 1-888-386-1300.
Please see DHCP letter on Importation of European Drug Product
Other

Fresenius Medical Care North America (New 03/13/2014)

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. (Reverified 11/22/2016)

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) Available Shortage per Manufacturer: Available Other
100 mL flexible container (NDC 0409-7984-23) Available Shortage per Manufacturer: Available Other
100 mL flexible container-4 pack (NDC 0409-7984-37) Available Shortage per Manufacturer: Available Other
150mL flexible container (NDC 0409-7983-61) Available Shortage per Manufacturer: Available Other
250mL Vis-IV container, PVC/DEHP-free (NDC 0409-7983-25) Available Shortage per Manufacturer: Available Other
250mL flexible container (NDC 0409-7983-02) Available Shortage per Manufacturer: Available Other
250mL flexible container 2 port (NDC 0409-7983-53) Available Shortage per Manufacturer: Available Other
250mL ADD-Vantage flexible container (NDC 0409-7101-02) Available Shortage per Manufacturer: Available Other
500mL flexible container 2 port (NDC 0409-7983-55) Available Shortage per Manufacturer: Available Other
500mL flexible container (NDC 0409-7983-03) Available Shortage per Manufacturer: Available Other
1000mL flexible container (NDC 0409-7983-09) Available Shortage per Manufacturer: Available Other

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