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. (Revised 11/15/2017)

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) Product on allocation to contracted customers Increased demand for the product
10% FreAmine III (Amino Acid Injection) in 1,000mL glass container, catalog S9010-SS, (NDC 0264-9010-55) Product on allocation to contracted customers Increased demand for the product
TrophAmine (10% Amino Acid Injection) in 500mL glass container, catalog S9341-SS, (NDC 0264-9341-55) Product on allocation to contracted customers Increased demand for the product
TrophAmine (6% Amino Acid Injection) in 500mL glass container, catalog S9361-SS, (NDC 0264-9361-55) Product on allocation to contracted customers Increased demand for the product

Baxter Healthcare (New 11/09/2017)

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), 2B0011 6% 500 mL (NDC 0338-1131-03) On allocation Other
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) On allocation Other
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) On allocation Other
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) On allocation Other
CLINIMIX E sulfite-free (Amino Acid with Electrolytes in Dextrose with Calcium) Injection in CLARITY Dual Chamber Container On allocation

Please see the attached list of all Baxter presentations/NDCs

Other
CLINIMIX sulfite-free (Amino Acid in Dextrose) Injection in CLARITY Dual Chamber Container On allocation

Please see the attached list of all Baxter presentations/NDCs

Other
SYNTHAMIN 17 without Electrolytes - 10% Amino Acids Intravenous Infusion 3000 mL. Product code FKB6642. Pack factor 3 (NDC 0338-9575-03) Limited quantities will be available in the next few weeks. Baxter will provide further updates as more product becomes 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

Other
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) Limited quantities will be available in the next few weeks. Baxter will provide further updates as more product becomes 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

Other
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) Limited quantities will be available in the next few weeks. Baxter will provide further updates as more product becomes 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

Other
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) Limited quantities will be available in the next few weeks. Baxter will provide further updates as more product becomes 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

Other

ICU Medical, Inc. (New 10/26/2017)

Company Contact Information:
877-946-7747

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
AMINOSYN 8.5%, Sulfite-Free, 500 mL (NDC 0409-4187-03) Next delivery and estimated recovery: TBD 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
AMINOSYN 10%, Sulfite-Free, 500 mL (NDC 0409-4191-03) Next delivery and estimated recovery: TBD 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
AMINOSYN 10%, Sulfite-Free, 1000 mL (NDC 0409-4191-05) Next delivery and estimated recovery: TBD 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
AMINOSYN 3.5% M, Sulfite-Free, 1000 mL (NDC 0409-4196-05) Next delivery and estimated recovery: TBD 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
AMINOSYN RF 5.2%, Sulfite-Free (Renal Formula), 500 mL (NDC 0409-4166-03) Next delivery and estimated recovery: TBD 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
AMINOSYN-HBC 7%, Sulfite-Free, 500 mL (NDC 0409-4168-03) Next delivery and estimated recovery: TBD 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
AMINOSYN™-PF 7%, Sulfite-Free, 500 mL (NDC 0409-4178-03) Next delivery and estimated recovery: TBD 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
AMINOSYN II 8.5%, With Electrolytes, Sulfite-Free, 500 mL (NDC 0409-4171-03) Next delivery and estimated recovery: TBD 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
AMINOSYN II 8.5%, Sulfite-Free, 500 mL (NDC 0409-4162-03) Next delivery and estimated recovery: TBD 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
AMINOSYN 10%, Sulfite-Free, 500 mL (NDC 0409-4164-03) Next delivery and estimated recovery: TBD 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
AMINOSYN 10%, Sulfite-Free, 1000 mL (NDC 0409-4164-05) Next delivery and estimated recovery: TBD 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
AMINOSYN II 10%, Sulfite-Free, (Pediatric Formula) 1000 mL (NDC 0409-4179-05) Next delivery and estimated recovery: TBD 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
Aminosyn II 10% Sulfite-Free BLK PK 2000 mL (NDC 0409-7172-17) Next delivery and estimated recovery: TBD 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
Aminosyn II 15% Sulfite-Free BLK PK 2000 mL (NDC 0409-7171-17) Next delivery and estimated recovery: TBD 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

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