Wyeth recalls 1,000-unit/mL heparin sodium injection

Wyeth Pharmaceuticals and ESI Lederle are voluntarily recalling all lots of heparin sodium injection, USP (porcine-derived) 1,000 units/mL, 1 mL Dosette vials, and 10 mL and 30 mL multiple-dose vials due to the presence of clear crystals containing an antioxidant compound from the vial rubber closures. This recall does not apply to the company’s 5,000 and 10,000 unit/mL heparin sodium products.

The 1,000 units/mL, 1 mL, 10 mL, and 30 mL vials will not be available for approximately six months. The company plans to increase production of the 5,000 units/mL, 10 mL multiple-dose vials. Until the 1,000 units/mL concentration becomes available again, monthly purchases will be limited for inventory management purposes. Wholesalers, distributors, and customers who buy direct will be limited to 150% of historical purchases for the 5,000 units/mL, 1 mL Dosette and 10 mL multiple-dose vial and the 10,000 units/mL, 1 mL Dosette and 4 mL multiple-dose vial presentations. Historical data are based on purchases made between July 2001 and March 2002.

For more information, see www.fda.gov/medwatch/SAFETY/2002/safety02.htm#hepari