FDA Drug Shortages

Current and Resolved Drug Shortages and Discontinuations Reported to FDA

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Amino Acids
Status: Resolved
»Duration of Shortage: 10/26/2017 - 09/24/2019
»Therapeutic Categories: Gastroenterology; Pediatric; Total Parenteral Nutrition

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B. Braun Medical Inc. (Revised 09/24/2019)

Company Contact Information:
800-227-2862

Presentation
  • 15% Amino Acid (Plenamine) in 1,000mL glass container, catalog S3200-SS, (NDC 0264-3200-55)
  • 10% FreAmine III (Amino Acid Injection) in 1,000mL glass container, catalog S9010-SS, (NDC 0264-9010-55)
  • TrophAmine (10% Amino Acid Injection) in 500mL glass container, catalog S9341-SS, (NDC 0264-9341-55)
  • TrophAmine (6% Amino Acid Injection) in 500mL glass container, catalog S9361-SS, (NDC 0264-9361-55)
  • 15% Amino Acid (Plenamine) Pharmacy Bulk Package in 1,000 mL plastic container, catalog S4500, (NDC 0264-4500-00)
Note:
  • N/A

Baxter Healthcare (Revised 09/24/2019)

Company Contact Information:
888-229-0001

Presentation
  • 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)
  • 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)
  • 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)
  • 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)
  • CLINIMIX E sulfite-free (Amino Acid with Electrolytes in Dextrose with Calcium) Injection in CLARITY Dual Chamber Container
  • CLINIMIX sulfite-free (Amino Acid in Dextrose) Injection in CLARITY Dual Chamber Container
  • SYNTHAMIN 17 without Electrolytes - 10% Amino Acids Intravenous Infusion 3000 mL. Product code FKB6642. Pack factor 3 (NDC 0338-9575-03)
  • 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)
  • 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)
  • 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)
Note:
  • N/A

ICU Medical, Inc. (Revised 09/24/2019)

Company Contact Information:
877-946-7747

Presentation
  • AMINOSYN™-PF 7%, Sulfite-Free, 500 mL (NDC 0409-4178-03)
  • AMINOSYN II 10%, Sulfite-Free, (Pediatric Formula) 1000 mL (NDC 0409-4179-05)
  • Aminosyn II 10% Sulfite-Free BLK PK 2000 mL (NDC 0409-7172-17)
  • Aminosyn II 15% Sulfite-Free BLK PK 2000 mL (NDC 0409-7171-17)
Note:
  • N/A

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