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Voluntary recall of heparin announced

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Last week, the FDA announced a voluntary recall issued by Scientific Protein Laboratories LLC for 23 lots of Heparin Sodium USP active pharmaceutical ingredient.

B. Braun Medical Inc., supplied by Scientific Protein Laboratories, was informed that one lot of heparin has a heparin-like contaminant and decided to recall the products on March 21 as a precautionary measure, though no adverse events have been reported. The recall includes 23 finished product lots manufactured and distributed in the United States and Canada.

A complete list of the recalled heparin lots is available on the FDA’s web site .

The FDA has already received reports of death and serious injuries among patients administered other heparin injectable products that contain this contaminant.

Customers who possess any of the recalled lots are urged to discontinue use immediately and report any adverse reactions or problems associated with the use of this product to the FDA’s MedWatch Adverse Event Reporting Program.

Typical symptoms include anaphylactic-like reactions, such as low blood pressure, shortness of breath, nausea, vomiting, diarrhea and abdominal pain, according to a notification from Scientific Protein Labs.

Infusion pumps issued Class I recall

Also last week, the FDA assigned a Class I recall to Implantable infusion pumps used to administer medication for pain, spasticity and cancer. The pumps were originally recalled in January after an increase in reports of inflammatory masses in patients.

The FDA issued a notice to healthcare professionals to alert them of the Class I recall based on a Jan. 16 letter from Medtronic Neuromodulation, manufacturer of SynchroMed and IsoMed implantable infusion pumps, to clinicians.

In that letter, Medtronic informed physicians of the increased rate of reported inflammatory masses in patients who received intrathecal drug delivery through its products, and offered patient management recommendations and diagnostic steps.

According to a press release, the FDA has issued approval for a device labeling update that will include these new data.

The risk for inflammatory mass formation has been included in the labeling for the implantable drug infusion pumps since 2001, according to Medtronic. – by Stacey L. Adams