FDA Drug Shortages

Current and Resolved Drug Shortages and Discontinuations Reported to FDA

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Potassium Chloride Injection
Status: Currently in Shortage
»Date first posted: 05/15/2012
»Therapeutic Categories: Gastroenterology; Endocrinology/Metabolism; Pediatric; Total Parenteral Nutrition

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B. Braun Medical Inc. (Reverified 10/23/2018)

Company Contact Information:
800-227-2862

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
250mL Potassium Chloride Injection Concentrate (2 mEq K/mL)(NDC 0264-1940-20) Product on allocation to contracted customers Manufacturing delays

Baxter Healthcare (Reverified 12/12/2018)

Company Contact Information:
888-229-0001

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
10 mEq/100 mL in sterile water (NDC 00338-0709-48) Available
20 mEq/100 mL in sterile water (NDC 00338-0705-48) Available
40 mEq/100 mL in sterile water (NDC 00338-0703-48) Available
20 mEq/50 mL in sterile water (NDC 00338-0703-41) Available
10 mEq/50 mL in sterile water (NDC 00338-0705-41) Available
20 mEq/1000 mL in lactated ringers and dextrose 5% (NDC 00338-0811-04) Available
20 mEq/1000 mL in 5% dextrose and 0.9% sodium chloride (NDC 00338-0803-04) Available
20 mEq/1000 mL in 0.9% sodium chloride (NDC 00338-0691-04) Available
40 mEq/1000 mL in 5% dextrose and 0.45% sodium chloride (NDC 00338-0675-04) Available
20 mEq/1000 mL in 5% dextrose (NDC 00338-0683-04) Available
40 mEq/1000 mL in 0.9% sodium chloride (NDC 00338-0695-04) Available
20 mEq/1000 mL in 5% dextrose and 0.45% sodium chloride (NDC 00338-0671-04) Available
20 mEq/L in 5% dextrose and 0.45% sodium chloride, 500 mL (NDC 00338-0671-03) Available
20 mEq/1000 mL in 0.45% sodium chloride (NDC 00338-0704-34) Available
40 mEq/1000 mL in 5% dextrose and 0.9% sodium chloride (NDC 00338-0807-04) Available
20 mEq/L in 5% dextrose and 0.2% sodium chloride, 500 mL (NDC 00338-0663-03) Available
20 mEq/1000 mL in 5% dextrose and 0.2% sodium chloride (NDC 00338-0663-04) Available
10 mEq/1000 mL in 5% dextrose and 0.45% sodium chloride (NDC 00338-0669-04) Available
30 mEq/1000 mL in 5% dextrose and 0.45% sodium chloride (NDC 00338-0673-04) Available

Fresenius Kabi USA, LLC (Revised 11/08/2018)

Company Contact Information:
888-386-1300

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
2 mEq/mL, 5 mL vials, (NDC 63323-0965-05) Backordered. Next release not available at this time. Manufacturing delay
2 mEq/mL, 10 mL vials, (NDC 63323-0965-10) Available Check wholesalers for inventory Manufacturing delay
2 mEq/mL, 15 mL vials, (NDC 63323-0965-15) Unavailable
2 mEq/mL, 20 mL vials, (NDC 63323-0965-20) Available Check wholesalers for inventory Manufacturing delay
2 mEq/mL, 30 mL vials, (NDC 63323-0967-30) Available Check wholesalers for inventory Manufacturing delay

Hospira, Inc. (Revised 12/06/2018)

Company Contact Information:
844-646-4398

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
10 mEq/5 mL (2 mEq/mL); Single Dose Glass Fliptop Vial (NDC 00409-6635-01) Available Other
2 mEq/mL; 15 mL vial (NDC 00409-6636-01) Discontinued Discontinuation of the manufacture of the drug
20 mEq/10 mL (2 mEq/mL); Single Dose Plastic Fliptop Vial (NDC 00409-6651-06) Limited Supply Available. Next Delivery and Estimated Recovery: December 2018 Demand increase for the drug
40 mEq/20 mL (2 mEq/mL); Single Dose Plastic Fliptop Vial (NDC 00409-6653-05) Limited Supply Available. Next Delivery and Estimated Recovery: January 2019 Demand increase for the drug

ICU Medical, Inc. (Revised 12/03/2018)

Company Contact Information:
877-946-7747

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
10 mEq/100 mL (NDC 0409-7074-26) 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
10 mEq/50 mL (NDC 0409-7075-14) Available to contracted customers only ICU Medical acquired these products from Hospira, a Pfizer company. For questions or inquiries regarding these Hospira labeled products, please contact ICU Medical. Other
20 mEq/100 mL, (NDC 0409-7075-26) 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
20 mEq/50 mL (NDC 0409-7077-14) 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
40 mEq/100 mL (NDC 0409-7077-26) 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
40 mEq/1000 mL (NDC 0409-7116-09) 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
20 mEq/1000 mL in 0.9% NaCl (NDC 0409-7115-09) 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
20 mEq/1000 mL in 5% dextrose (NDC 0409-7905-09) 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
20 mEq/1000 mL in 5% Dex/Lact Ringers (NDC 0409-7111-09) 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
10 mEq/500 mL in 5% dex & 0.225% NaCl (NDC 0409-7901-03) Product is being discontinued 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. Discontinuation of the manufacture of the drug
10 mEq/ 500 mL in 5% dex 0.45% NaCl (NDC 0409-7902-03) 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
20 mEq/1000 mL in 5% dex& 0.225% NaCl (NDC 0409-7901-09) 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
20 mEq/1000 mL in 5% dex& 0.45% NaCl (NDC 0409-7902-09) 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
30 mEq/1000 mL in 5% dex& 0.45% NaCl (NDC 0409-7903-09) 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
40 mEq/1000 mL in 5% dex& 0.45% NaCl (NDC 0409-7904-09) 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
10 mEq/1000 mL in 5% dex & 0.45% NaCl (NDC 0409-7993-09) 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
20 mEq/1000 mL in 5% dex & 0.9% NaCl (NDC 0409-7107-09) 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
40 mEq/1000 mL in 5% dex & 0.9% NaCl (NDC 0409-7109-09) 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
20 mEq/1000 mL in 0.45% NaCl (NDC 0409-9257-39) 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

Industria Farmaceutica Galenica Senese S.r.l. (Galenica)-distributed by Athenex Pharmaceutical Division, LLC (New 08/01/2018)

Company Contact Information:
855-273-0154

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
Potassium Chloride Injection, Concentrate, 2 mEq/mL; 10mL ampules; 10 ampules per carton (NDC 72439-500-10) Available Athenex Pharmaceutical Division, LLC (Athenex)in conjunction with FDA has initiated temporary importation of Potassium Chloride Injection, Concentrate, 2 mEq/mL manufactured and marketed in Italy by Industria Farmaceutica Galenica Senese S.r.l. (Galenica)- into the U.S. market to address drug shortages.

Dear Healthcare Provider Letter

Available

Laboratoire Aguettant (Aguettant) - distributed by La Jolla Pharmaceutical Company (New 08/21/2018)

Company Contact Information:
800-651-3861

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
Potassium Chloride Proamp® 0.15 g/mL (equivalent to 2 mEq/mL) 10ml ampule; 50 ampules per box (NDC 60710-015-50) Available Laboratoire Aguettant (Aguettant) in conjunction with FDA has initiated temporary importation of Potassium Chloride Proamp® 0.15 g/mL (equivalent to 2 mEq/mL) concentrated solution for infusion into the U.S. market to address drug shortages.

Dear Healthcare Provider Letter

Available

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