Defective Medical Products Law Blog

Herbal Science International Recall: Dietary Herbal Supplements

2008-04-11T11:16:00.000-07:00

The FDA has announced an Herbal Science International recall of dietary herbal supplements. Herbal Science International, Inc. (AKA Jen-On Herbal Science International, Inc.) has recalled twelve dietary supplements that contain ephedra, aristolochic acid or human placenta because they may present a serious health hazard to consumers, according to the FDA.

The company is recalling nine products that contain ephedra, a source of ephedrine alkaloids, as an ingredient sold labeled under the following brands:

Wu Yao Shun Qi San
Qing Bi Tang (Nasal Cleanser)
Zhong Fong Huo Luo Wan (Stroke Revito Formula)
Xiao Qing Long Tang (Little Green Dragon)
Ding Chuan Tang
Xiao Xu Ming Tang
Feng Shi Zhi Tong Wan (Joint Relief)
Guo Min Bi Yan Wan
Fang Feng Tong Sheng San

Herbal Science International, Inc. is also recalling Tou Tong San (Headache Formula) and Du Huo Ji Sheng Tang (Du Huo Joint Relief), two products containing aristolochic acid. Aristolochic acid is a potent carcinogen and nephrotoxin found in certain plants and botanicals. This chemical can cause serious kidney damage and the use of products that contain aristolochic acid has been associated with several occurrences of kidney failure. These products have also been linked to an increased risk of kidney cancer in people who have consumed them.

Finally, the company is recalling Seng Jong Tzu Tong Tan, a product that contains human placenta. Human placenta may transmit disease and dietary supplements that contain it may not be lawfully marketed in the United States.

All of the twelve products under voluntary recall are packed in white plastic bottles of 100 capsules. All lots are covered in this recall action. These products have been sold nationwide in herbal stores, by acupuncturists and on the internet.

The FDA has long regarded dietary supplements containing ephedra as potential health hazards because this botanical contains ephedrine alkaloids. Ephedrine alkaloids are adrenaline-like stimulants that can have potentially dangerous effects on the heart. Recent studies have confirmed that ephedrine alkaloids raise blood pressure and otherwise stress the circulatory system, effects that are linked to adverse health effects like heart attacks and strokes. Based on this and other evidence in the scientific literature, FDA issued a rule in February 2004 prohibiting the sale of dietary supplements containing ephedrine alkaloids because they present an unreasonable risk of illness or injury.

Read the full Herbal Science international recall announcement on the FDA website.

Posted April 2008.

Selenium in Total Body Formula

2008-04-11T10:21:00.000-07:00

On March 27, the FDA warned consumers not to purchase or use "Total Body Formula" in flavors Tropical Orange and Peach Nectar and "Total Body Mega Formula" in the Orange/Tangerine flavor of these products after receiving reports of adverse reactions in users in Florida and Tennessee (www.fda.gov/bbs/topics/NEWS/2008/NEW01812.html). The adverse reactions generally occurred after five to 10 days of daily ingestion of the product, and included significant hair loss, muscle cramps, diarrhea, joint pain, deformed fingernails, and fatigue.

The U.S. Food and Drug Administration announced today that it has found hazardous levels of selenium in samples of certain flavors of the dietary supplement products "Total Body Formula" and "Total Body Mega Formula." The FDA has received 43 reports of serious, adverse reactions from persons in nine states, Alabama, Florida, Georgia, Kentucky, Michigan, New Jersey, North Carolina, Tennessee, and Texas.

Analyses of samples of the products by FDA laboratories have now found most of the samples contain extremely high levels of selenium--up to 40,800 micrograms per recommended serving, or more than 200 times the amount of selenium per serving (i.e., 200 micrograms) indicated on the labels of the products.

Selenium, a naturally occurring mineral, is needed only in very small amounts for good health. Selenium can boost the immune system. Generally, normal consumption of food and water provides adequate selenium to support good health. Excessive intake of selenium is known to cause symptoms to include significant hair loss, muscle cramps, diarrhea, joint pain, fatigue, loss of finger nails and blistering skin.

Posted April 2008.

Baxter Heparin Recall Investigation Update

2008-03-05T20:18:00.000-08:00

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."

Fentanyl Patch Recall

2008-03-03T11:26:00.000-08:00

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.

B. Braun Heparin Syringe Recall

2008-01-28T21:05:00.000-08:00

B. Braun Medical Inc. was recently notified by its contract manufacturer, AM2PAT Inc., of a nationwide recall of all lots and sizes of Pre-filled Heparin and Saline Flush Syringes. (Read about the AM2Pat Inc. Heparin Recall.) This recall has prompted B. Braun Medical to recall its affected products, which includes the following Heparin syringes and normal saline flush syringes:

Normal Saline 3mL in 12 mL Syringe, Catalog #513584
Normal Saline 5mL in 12 mL Syringe, Catalog #513586
Normal Saline 10mL in 12 mL Syringe, Catalog #513587
10 units/mL Heparin, 5mL in 12 mL Syringe, Catalog #513610
100 units/mL Heparin, 3mL in 12 mL Syringe, Catalog #513611
100 units/mL Heparin, 5mL in 12 mL Syringe, Catalog #513612

Customers that have the recalled product in their possession should discontinue use immediately. Based on ongoing FDA inspection of AM2PAT Inc.'s facility, and CDC investigation it has been determined that there is a potential for the sterility of these affected products to be compromised, which may result in potential contamination. AM2PAT previously initiated a recall of one lot of Sierra Pre-Filled Heparin (lot #070926H) that was found to be contaminated with Serratia marcescens, which may lead to patient infections. CDC has confirmed growth of Serratia marcescens from several unopened syringes of this product in this specific AM2PAT lot. This type of bacterial infection could present a serious adverse health consequence that could lead to life-threatening injuries and/or death.

We are investigating cases involving Heparin products. To contact a lawyer at Pritzker | Ruohonen, please call toll-free at 1-888-377-8900 or submit the firm's free case consultation form.

Heparin Recall

2007-12-26T20:35:00.000-08:00

We have been contacted regarding the Heparin recall initiated by AM2 PAT, Inc. The recall includes one lot of Pre-Filled Heparin Lock Flush Solution USP (5 mL in 12 mL Syringes), Lot # 070926H. The CDC tested some of the Heparin syringes in the recalled lot and found contamination with Serratia marcescens. FDA believes that the contamination has resulted in patient infections, according to the FDA announcement of the Heparin recall.

Our law firm has been investigating a variety of injuries associated with Heparin products. For more information on this Heparin recall, please see the following:

To contact a lawyer at Pritzker | Ruohonen regarding the Heparin recall, please call toll-free at 1-888-377-8900 or submit the firm's free case consultation form.

Image of Serratia marcescens courtesy of Lee Baines Photography, all rights reserved.

Medication Error Links

2007-12-04T09:01:00.000-08:00

At Pritzker | Ruohonen, we represent people injured by medication errors and families of people who die as a result of medication errors. As a public service we are providing the following links to medication error information:

1. FDA information on Medication Errors http://www.fda.gov/cder/drug/MedErrors/default.htm

2. FDA Patient Safety News http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/

3. National Patient Safety Foundation http://www.npsf.org/

4. Agency for Healthcare and Patient Safety http://www.ahrq.gov/qual/errorsix.htm

5. Institute for Safe Medication Practices http://www.ismp.org/

Bumetanide and Norepinephrine: Look-Alike Vials

2007-11-29T11:18:00.000-08:00

One of the primary causes of medication errors is look-alike vials. Sometimes the error involves the same medication in similar-looking vials, as with Heparin medication errors that resulted in three infant deaths and the recent Heparin overdose cases at Cedars-Sinai Medical Center.

The look-alike medication errors can also involve different medications in similar-looking vials, as with bumetanide and norpinephrine, which are both made by Bedford Laboratories (see photo). Earlier this year, the Institute for Safe Medical Practices issued a look-alike alert for bumetanide and norepinephrine:

We’ve received four reports of look-alike confusion between bumetanide injection vials and norepinephrine injection vials, both made by Bedford Laboratories. In one case, a patient for whom 1 mg of bumetanide was ordered actually received the contents of a 4 mg vial of norepinephrine. A bin in the pharmacy marked ‘bumetanide’ had mistakenly been filled with several norepinephrine vials. The pharmacy technician and pharmacist did not notice the error during a dispensing check. A nurse also failed to notice the error. . . . We’ve contacted Bedford, and the company noted that the bumetanide cap had been changed to the color green last April. However, the error reported above occurred recently, suggesting that vials manufactured prior to April 2006 are still in use. Additionally, once the vial cap is removed from either product, the vials still look very similar.

If you need legal representation in a medication error case, please contact one of our medical malpractice attorneys. We represent people injured by medication errors throughout the United States. If you have been seriously injured, we will fly at our own expense to meet with you.

Posted November 2007.

Medtronic Defibrillator Lead Recall and Lawsuit

2007-11-27T19:18:00.000-08:00

Medtronic Defibrillator Lead Injury?

Medtronic, Inc. suspended distribution of its Sprint Fedelis Leads. These electrodes (thin wires) connect an implanted defibrillator directly to the heart. Medtronic reports that some of the leads have fractured resulting in either unnecessary shocking or to not operate at all. The recalled leads have the following model numbers: 6930, 6931, 6948 and 6949. If you have one of these leads and suffered problems because of it, please contact our firm for legal assistance. Read more about the Medtronic recall and a Medtronic lawsuit.

Pritzker | Ruohonen & Associates, P.A.
Suite 2950 45 South 7th Street
Minneapolis, MN 55402
888-377-8900
fhp@pritzkerlaw.com
www.pritzkerlaw.com

Haldol (Haloperidol)

2007-10-16T12:57:00.000-07:00

The WARNINGS section of the prescribing information for Haldol (haloperidol, an antipsychotic medication), a Johnson & Johnson product, has been revised to include a new cardiovascular (heart-related) subsection regarding cases of sudden death, QT prolongation and torsades de pointes(TdP) in patients treated with haloperidol, especially when given intravenously, or at doses higher than recommended. According to the FDA, “although injectable haloperidol is only approved by the FDA for intramuscular injection, there is considerable evidence that the intravenous administration of haloperidol is a relatively common off-label clinical practice.”

Of the 11 fatal cases of heart arrhythmia (ventricular tachycardia known as torsades de pointes) associated with the use of haloperidol (marketed as Haldol), 8 of them involved intravenous administration of the drug. The FDA has not approved haloperidol for intravenous use. Learn More