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
B. Braun Medical Inc. (Reverified 07/24/2018)
| 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 | Manufacturing interruptions and demand increase | |
| 0.9% NaCl 500mL bag, PVC/DEHP-free (NDC 00264-7800-10) | Product on allocation to contracted customers | Manufacturing interruptions and demand increase | |
| 0.9% NaCl 1000mL bag, PVC/DEHP-free (NDC 00264-7800-00) | Product on allocation to contracted customers | 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 | 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 | 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 | 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 (Reverified 08/29/2018)
| 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. | 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. | 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. | 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. | Other |
| 150 mL (NDC 00338-0049-01) | Unavailable | Demand increase for the drug | |
| 250 mL Product code 2B1322Q (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). On allocation. | Other | |
| 500 mL Product code 2B1323Q (NDC 00338-0049-03) | Available | Other | |
| 500 mL Non-PVC, Dripless Access Container (DAC) VIAFLO Container Product code UE1323D (NDC 0338-9543-04) | Available | Other | |
| 1000 mL Product code 2B1324X (NDC 00338-0049-04) | Available | Demand increase for the drug | |
| 1000 mL Non-PVC, Dripless Access Container (DAC) VIAFLO Container Product code UE1324D (NDC 0338-9543-06) | Available | Other | |
| 250 mL, Non-PVC, Dripless Access Container (DAC) VIAFLO Container Product code UE1322D (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). 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) | Available | 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) | Available | Other | |
| 0.9% Sodium Chloride Injection, USP, 25 mL VIAFLEX Plastic Container Quad Pack (NDC 0338-0049-10). Product code 2B1300 | Available | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Other |
Fresenius Kabi USA, LLC (Reverified 10/15/2018)
| Presentation | Availability and Estimated Shortage Duration | Related Information | Shortage Reason (per FDASIA) |
|---|---|---|---|
| Sodium Chloride Injection USP, 0.9%, 50mL (NDC 63323-623-53) | Available for direct orders. | Increase in demand | |
| Sodium Chloride Injection USP, 0.9%, 100mL (NDC 63323-623-61) | Available for direct orders. | Increase in demand | |
| Sodium Chloride Injection USP, 0.9%, 250mL (NDC 63323-623-74) | Available for direct orders. | 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)
| 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 10/11/2018)
| 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: October 2018; Estimated Recovery: March 2019 | Demand increase for the drug | |
| 100 mL (5-Pack); ADD-Vantage Flexible Container (NDC 00409-7101-67) | Limited Supply Available. Next Delivery: October 2018; Estimated Recovery: March 2019 | Demand increase for the drug | |
| 250 mL (Dual Pack); ADD-Vantage Flexible Container (NDC 00409-7101-02) | Limited Supply Available. Next Delivery: November 2018; Estimated Recovery: March 2019 | Demand increase for the drug |
ICU Medical, Inc. (Revised 10/03/2018)
| Presentation | Availability and Estimated Shortage Duration | Related Information | Shortage Reason (per FDASIA) |
|---|---|---|---|
| 50 mL flexible container (NDC 0409-7984-13) | 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 |
| 100 mL flexible container (NDC 0409-7984-23) | 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. | Demand increase for the drug |
| 100 mL flexible container-4 pack (NDC 0409-7984-37) | Next delivery: Mid October Estimated recovery: Late 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 |
| 150mL flexible container (NDC 0409-7983-61) | 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 |
| 250mL Vis-IV container, PVC/DEHP-free (NDC 0409-7983-25) | Next delivery: Early October Estimated recovery: Late 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 |
| 250mL flexible container (NDC 0409-7983-02) | 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 |
| 250mL flexible container 2 port (NDC 0409-7983-53) | 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 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 |
| 100 mL Vis-IV container, PVC/DEHP-free (NDC 0409-7984-11) | 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 |
| 50 mL flexible container (NDC 0409-7984-36) | Next delivery: Late October Estimated recovery: Late 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 |
| 25 mL flexible container (NDC 0409-7984-20) | Next delivery: Late October Estimated recovery: Late 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 |
| 50 mL Vis-IV container, PVC/DEHP-free (NDC 0409-7984-06) | Next delivery: Early October Estimated recovery: Early November | 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 |
Laboratorios Grifols, S.A. (Revised 03/01/2018)
| 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 | Other |
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