McNeil Consumer Healthcare has voluntarily recalled all available product lots of Tylenol Arthritis Pain Caplet 100 count bottles. In November 2009, five lots of this product were recalled due to consumer reports of an unusual moldy, musty, or mildew-like odor that was associated with nausea, stomach pain, vomiting and diarrhea. The odor is caused by the presence of a chemical believed to be the breakdown of a chemical used to treat wooden pallets that transport and store packaging materials.
But consumers beware: this phenomenon is not unusual. Packaging not only acts as a barrier against contamination but it is also a source of contamination. In most cases, it is not a question of whether packaging components will leach into a product, it’s a question of how much. And pharmaceutical products are not immune to leaching. As a result, regulatory agencies collect information in order to document the safety margins of these food and drug “leachables”. Still, there is no set guideline among the governmental agencies. For instance, last year, the Canadian government banned the use of BPA in baby bottles as a precautionary measure against the risk that its presence could cause endocrine disruption in children--the FDA and other foreign agencies dispute the Canadian’s safety margins.
Still, scientists are trying to come up with a packaging material that prevents leaching of products. While a fool proof solution is yet to be found, the most successful anti-leaching products are available, at a price--the containers sometime cost several times the price of the components they replace.
In the meantime, pharmaceutical companies like McNeil Consumer Healthcare will continue to voluntarily recall their contaminated products. For all contaminated products, the consumer should stop using the product and contact the manufacturer for instructions on a refund or replacement.

Labels: drugs, FDA, products, recall

There has been a nationwide recall of eleven lots of Cleviprex (clevidipine butyrate) injectable emulsion, indicated for treatment of hypertension. The recall is due to the potential presence of particulate matter found to be inert stainless steel particles. The particles could theoretically reduce blood flow in capillaries, cause mechanical damage to some tissues, or initiate acute or chronic inflammatory reactions. Reduced blood supply to tissues may lead to ischemia or organ insufficiency in the brain, kidney, liver, heart or lungs.


Click here for the Medicines Company recall notice.

Labels: Cleviprex, FDA, recall

Maclaren USA, manufacturer of baby strollers, has voluntarily recalled all their strollers after receiving reports of fingertip amputations of children who inadvertently placed their fingers in the hinges of the stroller. Maclaren received 15 reports of children placing their fingers in the stroller’s hinge mechanism, resulting in 12 reports of fingertip amputations in the United States.

The recall involves all Maclaren single and double umbrella strollers. The affected models include Volo, Triumph, Quest Sport, Quest Mod, Techno XT, Techno XLR, Twin Triumph, Twin Techno and Easy Traveler. The word “Maclaren” is printed on the stroller.

The strollers were sold at retailers nationwide from 1999 through November 2009 and were priced between $100 to $360.00

Consumers should stop using these strollers immediately and contact Maclaren USA at the firm’s recall hotline: (877) 688-2326 or at www.maclaren.us/recall.

This information provided through the U.S. Consumer Product Safety Commission (CPSC). You can reach the CPSC at the CPSC Recall Hotline at (800) 638-2772, or at www.cpsc.gov.

For more information please see:

http://www.cpsc.gov/CPSCPUB/PREREL/prhtml10/10033.html

To view a video clip please see:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm187420.htm

Labels: recall, strollers

This drug is reportedly linked to Michael Jackson’s Death

Two tainted lots of a generic version of a drug reportedly taken by Michael Jackson have been recalled by the drug maker. Teva Pharmaceuticals has voluntarily recalled Propofol, the generic version of Diprovan, which is a powerful anesthetic and sedative.

However, no link has been established between the drug and the singer's death. Jackson died June 25 of cardiac arrest. The CDC is not involved in the investigation into Jackson's death.

The CDC issued a health advisory Monday, stating two lots of a generic version of the drug had tested positive for endotoxin, a contaminant.

There are 40 reported events of patients developing high fevers and muscle aches after being injected with the drug. All of the people who had taken propofol recovered; only one was hospitalized and that patient was quickly discharged.

At high doses, endotoxin can lower blood pressure and cause much more serious reactions. A decrease in blood pressure can cause problems with the heart, said Dr. Arjun Srinivasan, the chief investigator on the recall for the Centers for Disease Control and Prevention.

Teva Pharmaceuticals is working with the FDA to determine how the contamination occurred and is voluntarily recalling the affected lots.

According to Teva, about 57,000 100 ml vials were recalled. With regard to the Jackson investigation, spokeswoman Denise Bradley said, “I can say the DEA did contact us about a specific lot number, and that lot number is not from the two we are recalling."

The affected lots are 31305429B and 31305430B. Healthcare professionals are advised to immediately stop using these lots of propofol.

The Associated Press and the Los Angeles Times, citing unidentified sources, have reported that police found the drug Diprivan, a brand-name version of propofol, among Jackson's medicines.

The FDA requests reports of adverse events with propofol are made to MedWatch. These voluntary reports will help FDA gather additional information related to this problem and assess its public health impact.

The FDA can be contacted via:

• https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm
• Regular Mail: Use FDA postage paid form 3500 and mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787
• Fax: 800-FDA-0178
• Phone: 800-FDA-1088

For more information please see: CNN's Reports on the Events or CDC Advisory Letter to Health Care Professionals

Labels: CDC, chills, diprovan, endotoxin, FDA, fever, Michael Jackson, Propofol, recall, Teva

The FDA warns consumers not to buy or use Hardcore Energize Bullet or New Whey liquid products sold in test tube-like vials because of suspected product tampering. Both products are recalled.

A utility knife blade was found in a vial of Hardcore Energize Bullet drink, manufactured in the United States and sold in Canada. A second blade was found in one vial of New Whey liquid products, manufactured and sold in the United States. There are no reported injuries.

Both Hardcore Energize Bullet and New Whey liquid products are manufactured by Protica Inc., of Whitehall, Pa.

Hardcore Energize Bullet liquid products are recalled by distributor iSatori Technologies of Golden, Colo. The liquid is packaged in 2.9 ounce clear vials. The flavors affected are: Blue Rage and Black Rush.

The affected lots for the Blue Rage liquid product are: 1961, 1962, and 1794. The affected lot for the Black Rush liquid product is 1963.

New Whey liquid products are recalled by distributor IDS of Oviedo, Fla. The liquid is packaged in 2.9 ounce clear vials. The flavors affected are New Whey Fruit Punch 25g and New Whey Blue Raspberry 42g.

The affected lot for the New Whey Fruit Punch liquid product is 1960. The affected lot for the New Whey Blue Raspberry liquid product is 1944.

The FDA encourages consumers and healthcare professionals to report adverse events and product quality issues to the FDA.

The FDA can be contacted via:

• https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm
• Regular Mail: Use FDA postage paid form 3500 and mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787
• Fax: 800-FDA-0178
• Phone: 800-FDA-1088

For more information please see: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm170500.htm

Labels: engery drink, FDA, hardcore, hardcore energize bullet, knife blade, new whey, recall

The FDA released a warning yesterday to consumers that Clarcon Biological Chemistry Laboratory is recalling some of their skin sanitizers and protectants due to the products containing high levels of bacteria.

Consumers should not use any Clarcon manufactured product and any products they possess should be thrown away. Inspections done on many of Clarcon’s over the counter skin sanitizers and protectants revealed high levels of disease causing bacteria. Some of these bacteria can cause infections in the skin and underlying tissue. The FDA warns that some of the resultant infections can cause serious damage, maybe even requiring medical attention and can result in permanent damage. The FDA is particularly concerned about risk of infections because many of Clarcon’s products are advertised as antimicrobial and to be used on open wounds, damaged skin, and to protect against infectious disease.

The FDA urges all health care professionals and consumers that experience any adverse reactions related to Clarcon’s products to contact the FDA’s MedWatch Adverse Event Reporting program at:
--Online --Regular Mail: use postage-paid FDA form 3500 and mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787 --Fax: 800-FDA-0178 --Phone: 800-FDA-1088

Some of the products being recalled include:
Citrushield Lotion
· Dermasentials DermaBarrier
· Dermassentials by Clarcon Antimicrobial Hand Sanitizer
· Iron Fist Barrier Hand Treatment
· Skin Shield Restaurant
· Skin Shield Industrial
· Skin Shield Beauty Salon Lotion
· Total Skin Care Beauty
· Total Skin Care Work

For more information, see the FDA news release:
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm164863.htm

See the consumer article:
http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm164845.htm

Labels: bacteria, Clarcon, Dermassentials, FDA, infection, recall, sanitizer, Skin Shield

On Monday, May 18, the FDA issued a class I recall for SmartMonitor 2 Infant Apnea Monitor. A class I recall is the highest recall level that can be issued and is only issued when a product has a reasonable probability of causing serious injury or death. The recalled Apnea monitor is manufactured by Respironics, a Pennsylvania based health care device manufacturer.

The SmartMonitor 2 is used by both hospitals and consumers alike. It is used as a monitoring device in order to continuously watch an infant’s breathing and heart rate. The recall was issued because the SmartMonitor2 can fail to alarm when an infant’s breathing stops or his/her heart rate drops to a dangerously low level. The models that are being recalled were manufactured between January 16, 2008 and November 13, 2008. They were distributed from January 13, 2008 to December 31, 2008. The model numbers being recalled include model 4002 and 4003. The serial numbers of the recalled models are 3000033364 through 3000038740. The FDA advises that all stop using the product immediately and to report any problems to their doctor and the FDA. Currently, there have been no recorded fatalities from this device.

More than 4,900 defective infant apnea monitors have been voluntarily recalled. The potential defect is the failure of the audible alarm, which may cause the alarm not to sound when it should. The FDA stated that on April 23, 2009 Respironics notified medical supply companies of the potential defect in the SmartMonitor 2 infant apnea monitors. Respironics wanted all monitors in the companies’ inventories retuned.
Customers with questions or concerns regarding the SmartMonitor2 infant apnea monitor recall may contact Respironics at 1-888-345-4630.The FDA requests that Health care professionals and consumers may report adverse reactions or quality problems related to the recalled infant apnea monitors to the FDA's MedWatch Adverse Event Reporting program via:
Online: www.fda.gov/MedWatch/report.htm
Regular Mail: use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm
FAX: 1-800-FDA-0178

For more information please see: http://www.fda.gov/MedWatch/safety/2009/safety09.htm#SmartMonitor
http://www.fda.gov/cdrh/recalls/recall-042309.html

Labels: apnea, children, devices, FDA, monitor, recall

The FDA is investigating deaths of two Delaware hospital patients that may be linked to the use of the anti-coagulating drug heparin. The FDA is also investigating life-threatening complications in other patients of the same hospital. In total, 5 patients who were administered heparin suffered complications. An independent laboratory is conducting the investigation. The official cause of the complications is unknown.
Baxter International manufactures the commonly used blood thinner, which has had issues with its safety track record. Last year, Baxter issued a recall on heparin. Though not known at this time, company officials believe that the bulk materials used in the heparin involved in Delaware cases came from North American-based Pfizer, unlike the bulk materials involved the tainted heparin from 2008's recall, which came from China. Heparin’s composition is largely derived from pig intestines, which is why China is a large supplier, as it is a major pork producer. Baxter claims that the recall resulted from the use of an adulterated product, referred to as oversulfated chondroitin sulfate, which came from a Chinese supplier. Baxter is based in Deerfield,
The contaminant found in the heparin recalled in 2008 has not been found in the heparin used by the Delaware patients. Baxter’s vast 2008 recall involved a form of the drug distributed in vials and occurred after numerous complications were linked to it, including complications suffered by Dennis Quaid and Kimberly Buffington’s newborn twins. The heparin involved in the Delaware cases is distributed via a different method than the heparin involved in last year’s recall.
For more information please see: http://www.chicagotribune.com/business/chi-tc-biz-brf-heparin-0512may12,0,2613571.story

Labels: anti-coagulating, China, death, Delaware, Dennis Quaid, FDA, Heparin, Pfizer, recall

The manufacturer of Hydroxycut, the brand name associated with several dietary supplements used to help with weight loss, issued a voluntary recall after the FDA issued an advisory on May 1, 2009. The advisory stated the liver damage being caused appears to be relatively rare, but the FDA wanted to warn consumers of unnecessary risks associated with the supplement. The voluntary recall includes 14 Hydroxycut products including Hydroxycut Regular Rapid Release Caplets, Hydroxycut Caffeine-Free Rapid Release Caplets, Hydroxycut Regular Drink Packets, Hydroxycut Liquid Shots, Hydroxycut 24, and Hydroxycut Natural, and others.

Prior to the FDA advisory, the agency received 23 reports of liver-related problems and at least one reported death associated with Hydroxycut products. According to the FDA, at least nine million packages of Hydroxycut products were sold last year. The agency has not yet determined which ingredients, dosages, or other health-related factors may be associated with risks related to these products, which contain a variety of ingredients, including herbal extracts.

Side effects associated with Hydroxycut products include jaundice, nausea, vomiting, light-colored stools, excessive fatigue, weakness, stomach or abdominal pain, itching, and loss of appetite. More severe adverse reactions have included severe liver damage.

For more information about the FDA warning, see http://www.fda.gov/bbs/topics/NEWS/2009/NEW02006.html

For more information about the Hydroxycut recall, see http://www.fda.gov/oc/po/firmrecalls/iovate205_09.html

Labels: jaundice, liver damage, recall

Biosite and FDA notified healthcare facilities and clinicians of the recall of Biosite® brand Triage Cardiac Panel
Biosite and the Food and Drug Administration have recently notified emergency room and hospital laboratory personnel of a Class 1 recall of the Biosite brand Triage Cardiac Panel. FDA defines a Class 1 recall as “the most serious type of recall and involves situations in which there is a reasonable probability that use of these products will cause serious injury or death. “
The Biosite ®Triage Cardiac Panel is a test used by hospitals and clinics to assist medical professionals in making the diagnosis of a heart attack. On April 27, 2009, the company sent an urgent recall notice to hospitals and clinics. Facilities were instructed to immediately stop using the tests, and to throw away all packages showing the recalled lot number. Using test kits from the defective lot may lead to false negative results in blood samples containing very low levels of the blood markers used to determine heart damage.
These inaccurate test results can possibly mean that heart attacks, especially in the early stages, were incorrectly diagnosed or missed completely as clinicians relied on incorrect test results as a part of making a correct diagnosis. The defective test kits might not have been sensitive enough to detect low levels of the blood markers to indicate that a person had a heart attack or other damage to the heart muscle.
Testing packets with the recalled lot number were sold to hospitals and clinics from January 24, 2009 through February 17, 2009. If you or a loved one has recently been treated for heart related chest pain or other heart related symptoms, and early signs of a heart attack were missed or incorrectly diagnosed, you may be entitled to compensation.
If you would like to view the complete recall notice, you may do so at:
http://www.fda.gov/medwatch/safety/2009/safety09.htm#Panel

Labels: Biosite, cardiac, heart attack, javascript:void(0) class 1, misdiagnose, panel, recall, triage

Schnucks announced a voluntary recall yesterday on Schnucks brand olives as some of the jars may contain shards of glass.

The recalled olives come in 5.75 ounce jars with the UPC code: 04131819003, and a date of "best by" 02/06/11.

For more information, see http://www.schnucks.com/pressreleases/pressrelease.asp?id=6.

If you or someone you love has been injured by a defective product, you may be entitled to compensation. Contact the expert lawyers at Schlichter, Bogard and Denton for a free consultation.

Labels: attorney, attorneys, glass, lawyer, lawyers, olives, recall, Schnucks, shnucks spanish olives, spanish olives