Prefilled Syringes Recalled

January 9, 2008
BioPharm International Editors

AM2 PAT, Inc., (Angier, NC) has initiated a nationwide recall of one lot of prefilled Heparin Lock Flush Solution USP (5 mL in 12 mL Syringes), Lot # 070926H.

AM2 PAT, Inc., (Angier, NC) has initiated a nationwide recall of one lot of prefilled Heparin Lock Flush Solution USP (5 mL in 12 mL Syringes), Lot # 070926H. The heparin IV flush syringes, used by patients at home to flush and prevent clotting in IV lines and catheters, have been found to be contaminated with Serratia marcescens, which has resulted in patient infections. The Centers for Disease Control and Prevention (CDC) has confirmed growth of S. marcescens from several unopened syringes of this product. This type of bacterial infection could present a serious adverse health consequence that could lead to life-threatening injuries or death.

The Food and Drug Administration (FDA) has advised consumers and user facilities that have these recalled pre-filled syringes to stop using the product immediately. The affected product should be immediately quarantined and returned to its distributor.

The firm has voluntarily recalled the product after confirming bacterial contamination in some end user samples. The product was distributed in Florida, Texas, Illinois, Colorado, and Pennsylvania.

The FDA has reported from its ongoing inspection of AM2 PAT, Inc.’s facility, it appears that the firm is not in compliance with the Quality System regulation and failed to have adequate controls to ensure necessary sterility of its prefilled syringes. The firm is continuing to work with FDA and CDC to monitor this situation and FDA will provide continuing updates.

There are several lawsuits now pending as a result of the contaminated syringes.

FDA release

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