American Health Packaging  (AHP, Valley Forge, PA), B. Braun Medical Inc. (Irvine, CA), and Covidien  (Mansfield, MA), have all announced voluntary recalls of heparin products after  being notified by their supplier, Scientific Protein Laboratories LLC (SPL,  Waunakee, WI), of a nationwide recall of heparin sodium USP active  pharmaceutical ingredient (API) because of a heparin-like contaminant. 

  On March 20, American  Health Packaging announced a recall of 1,421 units (25 vials per unit) of  10,000 USP units/mL heparin sodium injection 1 mL vials. The vials were  manufactured by Baxter Healthcare (Deerfield, IL) and then placed by AHP into  individually labeled bags for use in pharmacy automation equipment. The AHP  packages where sold to five hospitals in Georgia and California.

  On March 21, B. Braun  Medical recalled 23 finished product lots, manufactured by B Braun and  distributed in the US and Canada. 

  On March 28, Covidien  recalled 32 lots of prefilled heparin lock flush syringes that were  manufactured and distributed in the US.

  All three companies have  recalled their products as a precautionary measure. None of the companies have  received adverse event reports related to their products.

  The Food and Drug  Administration has received reports of serious injuries and deaths in patients  who have been administered heparin injectable products made by Baxter from API  supplied by SPL that contained a heparin-like contaminant. Typical symptoms  include anaphylactic-like reactions such as low blood pressure, shortness of  breath, nausea, vomiting, diarrhea, and abdominal pain.

For more information on the heparin  situation, see 

FDA Issues Border Alert for All Heparin  Products

German Ministry of Health Recalls  Heparin Products

FDA Finds "Heparin-like"  Contaminant in Heparin API

Baxter Expands Heparin Recall, FDA  Issues 483 to China Facility

Letters Sent to Baxter and FDA Request  Answers on Heparin Situation

News

American Health Packaging (AHP, Valley Forge, PA), B. Braun Medical Inc. (Irvine, CA), and Covidien (Mansfield, MA), have all announced voluntary recalls of heparin products after being notified by their supplier, Scientific Protein Laboratories LLC (SPL, Waunakee, WI), of a nationwide recall of heparin sodium USP active pharmaceutical ingredient (API) because of a heparin-like contaminant.