FDA Drug Shortages

Current and Resolved Drug Shortages and Discontinuations Reported to FDA

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Amino Acids
Status: Currently in Shortage
»Date first posted: 10/26/2017
»Therapeutic Categories: Gastroenterology; Pediatric; Total Parenteral Nutrition

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B. Braun Medical Inc. (Reverified 07/10/2019)

Company Contact Information:
800-227-2862

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
15% Amino Acid (Plenamine) in 1,000mL glass container, catalog S3200-SS, (NDC 0264-3200-55) Available Increased demand for the product
10% FreAmine III (Amino Acid Injection) in 1,000mL glass container, catalog S9010-SS, (NDC 0264-9010-55) Available Increased demand for the product
TrophAmine (10% Amino Acid Injection) in 500mL glass container, catalog S9341-SS, (NDC 0264-9341-55) Available Increased demand for the product
TrophAmine (6% Amino Acid Injection) in 500mL glass container, catalog S9361-SS, (NDC 0264-9361-55) Available Increased demand for the product
15% Amino Acid (Plenamine) Pharmacy Bulk Package in 1,000 mL plastic container, catalog S4500, (NDC 0264-4500-00) Available

Baxter Healthcare (Reverified 08/14/2019)

Company Contact Information:
888-229-0001

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
PREMASOL - sulfite-free (Amino Acid) Injection in VIAFLEX Plastic Container. Pharmacy Bulk Package. Not for Direct Infusion. Product Codes: 2B0009 10% 1000 mL (NDC 0338-1130-04), 2B0010 10% 2000 mL (NDC 0338-1130-06), 2B0012 10% 500 mL (NDC 0338-1130-03) Available
10% TRAVASOL (Amino Acid) Injection in VIAFLEX Plastic Container. Pharmacy Bulk Package. Not for Direct Infusion. Product Codes: 1B6624 10% 1000 mL (NDC 0338-0644-04), 1B6623 10% 500 mL (NDC 0338-0644-03), 1B6626P 10% 2000 mL (NDC 0338-0644-06) Available
15% CLINISOL - sulfite-free (Amino Acid) Injection in VIAFLEX Plastic Container. Pharmacy Bulk Package. Not for Direct Infusion. Product Codes: 2B6189 15% 2000 mL (NDC 0338-0502-06), 2B6187 15% 500 mL (NDC 0338-0502-03) Available
20% PROSOL - sulfite-free (Amino Acid) Injection, 2000 mL VIAFLEX Plastic Container. Pharmacy Bulk Package. Not for Direct Infusion. Product Code 2B6186 (NDC 0338-0499-06) Available
CLINIMIX E sulfite-free (Amino Acid with Electrolytes in Dextrose with Calcium) Injection in CLARITY Dual Chamber Container Available

Please see the attached list of all Baxter presentations/NDCs

CLINIMIX sulfite-free (Amino Acid in Dextrose) Injection in CLARITY Dual Chamber Container Available

Please see the attached list of all Baxter presentations/NDCs

SYNTHAMIN 17 without Electrolytes - 10% Amino Acids Intravenous Infusion 3000 mL. Product code FKB6642. Pack factor 3 (NDC 0338-9575-03) Available Baxter Healthcare Corporation in conjunction with FDA has initiated temporary importation of SYNTHAMIN 17 without electrolytes - 10% Amino Acid Intravenous Infusion into the U.S. market to address drug shortages.

Dear Health Care Letter, United Kingdom

CLINIMIX N9G15E-Solution for Infusion, 1000 mL (2.75% Amino Acid in 7.5% Glucose with Electrolytes). Product code FKB6669C - Pack factor of 8 (NDC 0338-9570-08) Available Baxter Healthcare Corporation in conjunction with FDA has initiated temporary importation of CLINIMIX-Solution for Infusion (with electrolytes) into the U.S. market to address drug shortages.

Dear Health Care Letter, United Kingdom

CLINIMIX N9G20E-Solution for Infusion, 1000 mL (2.75% Amino Acid in 10% Glucose with Electrolytes) Product code FKB6670C - Pack factor of 8 (NDC 0338-9566-08) Available Baxter Healthcare Corporation in conjunction with FDA has initiated temporary importation of CLINIMIX-Solution for Infusion (with electrolytes) into the U.S. market to address drug shortages.

Dear Health Care Letter, United Kingdom

CLINIMIX N14G30E-Solution for Infusion, 2000 mL (4.25% Amino Acid in 15% Dextrose with Electrolytes) Product code FKB6654V - Pack factor of 4 (NDC 0338-9587-04) Available Baxter Healthcare Corporation in conjunction with FDA has initiated temporary importation of CLINIMIX-Solution for Infusion (with electrolytes) into the U.S. market to address drug shortages.

Dear Health Care Letter, United Kingdom

ICU Medical, Inc. (Reverified 08/13/2019)

Company Contact Information:
877-946-7747

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
AMINOSYN™-PF 7%, Sulfite-Free, 500 mL (NDC 0409-4178-03) 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
AMINOSYN II 10%, Sulfite-Free, (Pediatric Formula) 1000 mL (NDC 0409-4179-05) 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
Aminosyn II 10% Sulfite-Free BLK PK 2000 mL (NDC 0409-7172-17) 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
Aminosyn II 15% Sulfite-Free BLK PK 2000 mL (NDC 0409-7171-17) 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

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