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U.S. Department of Health and Human Services

FDA Drug Shortages

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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 reported: 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)

B. Braun Medical Inc. (Reverified 07/16/2014)

Company Contact Information:
800-227-2862

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
250mL bag, PVC/DEHP-free (NDC 00264-7800-20) Intermittent interruptions in supply Please see Dear Customer Letter (PDF)

Dear Customer Letter

Demand increase for the drug
500mL bag, PVC/DEHP-free (NDC 00264-7800-10) Intermittent interruptions in supply Please see Dear Customer Letter (PDF)

Dear Customer Letter

Demand increase for the drug
1000mL bag, PVC/DEHP-free (NDC 00264-7800-00) Intermittent interruptions in supply Please see Dear Customer Letter (PDF)

Dear Customer Letter

Demand increase for the drug

Baxter Healthcare (Reverified 09/29/2014)

Company Contact Information:
888-229-0001

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
Sodium Chloride 0.9% w/v Intravenous Infusion in Viaflo® Non-PVC Containers, (UK/ English label) Viaflo® container sizes: 500 mL (NDC 0338-9542-02) Available beginning mid-May 2014 Baxter Healthcare Corporation in conjunction with FDA has initiated temporary importation of Sodium Chloride 0.9% w/v Intravenous Infusion in Viaflo® Non-PVC Containers into the U.S. market to address this shortage. Please see the Dear Healthcare Professional Letter (PDF – 529KB) for additional product and supply information. Also attached are the Viaflo® Instructions for Use (IFU, PDF – 138KB) containing important information on use of the Viaflo® products. All orders must be placed with Baxter Healthcare Corporation Customer Service at 1-888-229-0001.

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


Viaflo Instructions for Use
Other
Sodium Chloride 0.9% w/v Intravenous Infusion in Viaflo® Non-PVC Containers, (UK/ English label) Viaflo® container sizes: 1000 mL (NDC 0338-9542-06) Product Code FE1324D Available beginning June 2014 Baxter Healthcare Corporation in conjunction with FDA has initiated temporary importation of Sodium Chloride 0.9% w/v Intravenous Infusion in Viaflo® Non-PVC Containers into the U.S. market to address this shortage. Please see the Dear Healthcare Professional Letter (PDF – 529KB) for additional product and supply information. Also attached are the Viaflo® Instructions for Use (IFU, PDF – 138KB) containing important information on use of the Viaflo® products. All orders must be placed with Baxter Healthcare Corporation Customer Service at 1-888-229-0001.

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


Viaflo Instructions for Use
Other
150mL (NDC 00338-0049-01) Unavailable- anticipate production to resume in 4Q 2014.

Please see the Dear Valued Baxter Customer Letter dated December 16, 2013 for additional information.


Please see the Dear Valued Baxter Customer Letter dated March 12, 2014 for additional information.
Demand increase for the drug
250 mL (NDC 00338-0049-02) Baxter has this product on allocation.

Please see the Dear Valued Baxter Customer Letter dated December 16, 2013 for additional information.


Please see the Dear Valued Baxter Customer Letter dated March 12, 2014 for additional information.
Demand increase for the drug
250mL, PVC/DEHP-free (NDC 00338-6304-02) Baxter has this product on allocation.

Please see the Dear Valued Baxter Customer Letter dated December 16, 2013 for additional information.


Please see the Dear Valued Baxter Customer Letter dated March 12, 2014 for additional information.
Demand increase for the drug
500 mL (NDC 00338-0049-03) Baxter has this product on allocation.

Please see the Dear Valued Baxter Customer Letter dated December 16, 2013 for additional information.


Please see the Dear Valued Baxter Customer Letter dated March 12, 2014 for additional information.
Demand increase for the drug
500 mL, PVC/DEHP-free (NDC 00338-6304-03) Baxter has this product on allocation.

Please see the Dear Valued Baxter Customer Letter dated December 16, 2013 for additional information.


Please see the Dear Valued Baxter Customer Letter dated March 12, 2014 for additional information.
Demand increase for the drug
1000 mL (NDC 00338-0049-04) Baxter has this product on allocation.

Please see the Dear Valued Baxter Customer Letter dated December 16, 2013 for additional information.


Please see the Dear Valued Baxter Customer Letter dated March 12, 2014 for additional information.
Demand increase for the drug

Fresenius Kabi USA, LLC (Reverified 09/11/2014)

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) 50 mL (NDC 63323-623-50) Available Importation began March 2014. Limited quantities available through direct order.

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) 100 mL (NDC 63323-623-00) No further 100 mL will be available. See 50 mL, 500 mL, or 1L 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. Limited quantities available through direct order.

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) 500 mL (NDC 63323-623-59) 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. Importation began March 2014. Limited quantities available through direct order.

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) 1000 mL (NDC 63323-623-10) 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. Importation began March 2014. Limited quantities available through direct order.

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: 50 mL (NDC 63323-623-57) No further Scandinavian inventory available. Please see English label sizes for availability 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: 100 mL (NDC 63323-623-09) No further Scandinavian inventory available. Please see English label sizes for availability 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. Please see English label sizes for availability 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

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. (Revised 09/18/2014)

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 September 2014. Estimated recovery September 2014. Please check with your wholesaler for inventory. Demand increase for the drug
100 mL flexible container (NDC 0409-7984-23) Next delivery October 2014. Estimated recovery October 2014. Please check with your wholesaler for inventory. Demand increase for the drug
100 mL flexible container-4 pack (NDC 0409-7984-37) Next delivery September 2014. Estimated recovery September 2014. Please check with your wholesaler for inventory. Demand increase for the drug
150mL flexible container (NDC 0409-7983-61) Next delivery late September 2014; Estimated recovery late September 2014 Please check with your wholesaler for inventory. Sustained heavy demand. Customer allocations set at 100% historic usage. Demand increase of the drug
250mL Vis-IV container, PVC/DEHP-free (NDC 0409-7983-25) Product on allocation Please check with your wholesaler for inventory. Shortage per manufacturer: available. Sustained heavy demand. Customer allocations set at 100% historic usage. Other
250mL flexible container (NDC 0409-7983-02) Next delivery September 2014; Estimated recovery 4Q 2014. Please check with your wholesaler for available inventory. Sustained heavy demand. Customer allocations set at 100% historic usage. Demand increase for drug
250mL flexible container 2 port (NDC 0409-7983-53) Limited supply available Please check with your wholesaler for inventory. Shortage per manufacturer: Limited supply available. Sustained heavy demand. Customer allocations set at 100% historic usage. Other
250mL ADD-Vantage flexible container (NDC 0409-7101-02) Available Please check with your wholesaler for available inventory. Shortage per Manufacturer: Available. Sustained heavy demand. Customer allocations set at 100% historic usage. Other
500mL flexible container 2 port (NDC 0409-7983-55) Product on allocation Please check with your wholesaler for inventory. Shortage per manufacturer: available. Sustained heavy demand. Customer allocations set at 100% historic usage. Other
500mL flexible container (NDC 0409-7983-03) Next delivery September 2014. Estimated recovery TBD. Please check with your wholesaler for available inventory Sustained heavy demand. Customer allocations set at 100% historic usage. Demand increase for the drug
1000mL flexible container (NDC 0409-7983-09) Next delivery September 2014. Estimated recovery TBD. Please check with your wholesaler for available inventory Sustained heavy demand. Customer allocations set at 100% historic usage. Demand increase for the drug
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