Pritzker | Ruohonen Defective Medical Products Blog

Baxter Heparin Recall Investigation Update

At least 19 people have died recently after being administered heparin. Many others have had severe adverse reactions. Prompted by these adverse reactions, Baxter Healthcare recalled all of their multi-dose and single-use vials of heparin sodium for injection, and their heparin lock flush solutions. (Read about Baxter's heparin recall.)

According to Reuters, an investigation by the FDA has found that the Baxter heparin products may be contaminated with a heparin-like chemical:

U.S. regulators on Wednesday said they identified a contaminant in the key ingredient in Baxter International's recalled blood thinning drug heparin amid 15 more reports of deaths in patents treated with some version of the drug.

The contaminant, a large complex molecule chemically similar to heparin, was detected in samples from a Chinese and a U.S. plant, both owned by Baxter's supplier, Wisconsin-based Scientific Protein Laboratories LLC (SPL).

"At this point we don't know how the heparin-like compound got into the active pharmaceutical ingredient," Food and Drug Administration Deputy Commissioner Janet Woodcock told reporters on a conference call. "We don't yet have a direct causal link between the contaminant and the adverse events."

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Fentanyl Patch Recall

Actavis Inc. has announced that its subsidiary Actavis South Atlantic LLC is proceeding with the voluntarily recall from wholesalers and pharmacies of all lots of Fentanyl transdermal system CII patches sold in the United States.

This Fentanyl patch recall is an expansion of an initial Fentanyl recall of fourteen lots of Fentanyl transdermal patches announced on February 17, 2008 (Fentanyl recall - Fentanyl death - Fentanyl overdose). That recall was due to the identification of a possible fold-over defect present in the product that potentially could cause leakage of the Fentanyl gel. The remaining lots of Fentanyl transdermal system patches are being recalled as a precautionary measure because Actavis lacks assurance that all patches are free from defects.

Fentanyl patches are dangerous, and anyone coming in contact with the Fentanyl gel within the patch is at risk for serious adverse events, including respiratory depression and possible overdose, which may cause death.

If you are using a Fentanyl patch and have not experienced any adverse events, you need to contact your medical provider immediately.

If you believe you have been injured by Fentanyl, contact one of our lawyers regarding this Fentanyl patch recall and other Fentanyl recalls. You may be entitled to compensation for your injuries. If a family member died after using a Fentanyl patch, contact us for information on wrongful death litigation. To contact us, please call toll-free at 1-888-377-8900 or submit our free case consultation form.

Again, this Fentanyl patch recall is extremely serious and all caution should be used regarding the Fentanyl patches. We urge you to contact your medical provider immediately if you are using a Fentanyl patch. We also urge you to send this information to anyone you know who may be using a Fentanyl patch.

Posted March 2008.

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