Heparin Sodium Shortage Update 3/9/2010

3/10/2010
The FDA reports a shortage of heparin sodium large-volume premixed infusion solutions by the following manufacturers:

• B. Braun (1-800-227-2862). Shortage of heparin sodium drug substance that meets current qualification requirements. The company is currently completely out of heparin sodium in 5% dextrose injection (40 units/mL, 50 units/mL, and 100 units/mL) product codes, is working to resolve the issues that have led to the shortage, and will produce additional information as soon as availability information becomes known. Heparin sodium in 0.9% sodium chloride injection (2 units/mL) is currently available.

• Baxter (1-888-229-0001). Shortage of finished product that meets current specifications. The company is working to resolve the shortage issues but no availability timeline reported. Heparin sodium 1,000 units/500 mL in 0.9% sodium chloride and heparin sodium 2,000 units/1,000 mL in 0.9% sodium chloride are currently available.

• Hospira (1-877-946-7747). Heparin sodium shortage and unexpected issues implementing the new United States Pharmacopeia (USP) heparin monograph. The company has resumed manufacturing heparin sodium large-volume premix solutions and expects all backorders to be cleared by early April. Hospira is working to resolve the issues that have led to the shortage of its heparin sodium iSecure products, and currently has no inventory available, but anticipates inventory to become available in early May. The high-dose heparin Flip Top products currently available include 1,000 units/mL 1 mL/2 mL, 1,000 units/mL 10 mL, 1,000 units/mL 30 mL/50 mL, 10,000 units/mL 1 mL, 5,000 units/mL 1 mL/2 mL, and 5,000 units/mL 10 mL vials. The Carpuject Luer Lock products currently available include 10 units/mL, 20 units/2 mL, 30 units/3 mL, 50 units/5 mL, 100 units/mL, 200 units/2 mL, 300 units/3 mL, 500 units/5 mL, 5,000 units/0.5 mL, and 5,000 units/mL syringes.

• APP (1-888-386-1300). Continues to have all high-dose heparin sodium injectable vials available, including those suitable for compounding large volume infusion solutions.

Clin-eguide™ is an online clinical decision support tool that provides the most accurate evidence-based information for health care providers in the clinical setting. It integrates trusted content from Ovid, Facts & Comparisons®, and Lippincott Williams and Wilkins, as well as other premier publishers.