AM2 PAT, Inc. Pre-filled Heparin and Saline Flush Syringes Recalled Due to Contamination

January 18, 2008—The FDA issued a nationwide recall of all lots and sizes of pre-filled Heparin Lock Flush and Normal Saline IV Flush Syringes after discovering several lots were contaminated with Serratia marcescens, a bacteria linked to serious infections that could lead to life-threatening injuries and/or death. Serratia marcescens is a bacterium found in water and soil that has been known to cause pneumonia, blood infections, urinary tract and wound infections.

Heparin sodium is an anticoagulant (blood thinner) used in patients undergoing kidney dialysis, certain types of cardiac surgery, and treatment of other serious medical conditions, including deep vein thrombosis and pulmonary emboli. Heparin is administered intravenously, by injection, directly into the bloodstream.

The recalled syringes were manufactured by AM2 PAT, Inc. of North Carolina under the brand names Sierra Pre-filled and B. Braun, and sold in fill sizes of 3mL, 5mL and 10mL, and syringe sizes of 6mL and 12mL. This recall is an expansion of AM2 PAT Inc.’s previous December 2007 voluntary recall of a single lot of Pre-Filled Heparin Lock Flush Solution USP for contamination with the same bacterium.

Baxter’s Single and Multiple-dose Vial Heparin Products Linked to Severe Allergic Reaction

February 28, 2008—Baxter Healthcare has announced that it is extending its recall of all remaining lots of multi-dose Heparin vials to include single-dose vials of Heparin, as well as their HEP-LOCK Heparin flush solutions. As part of this recall, on March 20, 2008, American Health Packaging (AHP), a subsidiary of AmerisourceBergen Corp. announced a voluntary recall of 1,421 units (25 vials per unit) of 10000 USP units/ml heparin sodium injection 1 ml vials. The vials were manufactured by Baxter, then placed by AHP into individually labeled bags for use in pharmacy automation equipment, and sold to five hospitals in GA and CA.

February 11, 2008--Baxter Healthcare Corp. temporarily suspended the manufacture of multi-dose vials of Heparin sodium for injection, after reports of serious allergic reaction and low blood pressure in patients receiving high “bolus” doses of the drug. Serious adverse events, including allergic or hypersensitivity-type reactions, with symptoms of oral swelling, nausea, vomiting, sweating, shortness of breath, and cases of severe hypotension (low blood pressure) have been reported in patients who received higher bolus doses of heparin.

Over 1 million multiple-dose vials of heparin are sold each month in the U.S., half of which are manufactured and distributed by Baxter. Heparin sodium is an injectable blood thinning drug made from pig intestines that is widely used in kidney dialysis and before certain types of surgery and procedures, including cardiac bypass surgery and photopheresis.

On January 17, 2008 Baxter Healthcare and the FDA had notified healthcare professionals and patients of a voluntary recall of nine product lots of Heparin as a precaution due to an increase in adverse patient reactions. Since late December 2007 Baxter and the FDA have received approximately 350 reports of adverse reactions, 40% of which have been serious; 4 deaths have been reported.

According to the FDA, multiple-dose vials of heparin manufactured by Baxter that are currently in distribution will not be recalled and Baxter will continue to make single-dose vials.