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Fairfield Pharmaceutical Products Law Blog

Knee replacement manufacturer recalls components

Knee replacements are a common procedure that is performed all across the country, including in hospitals and surgical centers in Connecticut. Patients who have been through this procedure understand the expense, pain and recovery involved. Naturally, they expect that the equipment used is of good quality and free of defects. Recently, a recall was issued by Zimmer Holdings, Inc., the manufacturer of the NexGen Complete Knee Solution system, for an issue with the tibial components that could lead to device failure.

The system’s manufacturer claims that a possible problem was found regarding the thread specifications, which could lead to a host of complications. These complications include post-surgical infection, bone loss, dislocation and early revision surgery. While this particular device is supposed to be installed in a less invasive surgery, sparing patients from the pain typically associated with this type of procedure, the assembly process surgeons must use is said to make the problems more apparent.

Solution recalled over mold issue that may cause injury

Recently, Hospira Inc. issued a recall of a solution they produce after receiving reports of a possible particulate issue. The particulate found in some bottles of the solution in question is believed to be a mold that -- if injected -- could cause injury to the patient. This is a nationwide recall that could affect residents of Connecticut.

The recall extends to a several units of Lactated Ringers and 5 percent Dextrose Injection, which is essentially a fluid and electrolyte replacement solution. The lot being recalled was distributed between Dec. 2013 and Feb. 2014 to a number of facilities including hospitals, distributors and clinics, and has an expiration date of Nov. 2015. At this time, no adverse medical events have been reported, but the recall was issued as a safety measure.

Less invasive treatment for fibroids may cause harm to patients

The typical treatment for fibroids involves a full-blown hysterectomy. As this is considered a major surgery, involving weeks of recovery time, doctors and patients are often excited for new technologies that reduce the stress surgery can place on the body by providing a less invasive approach. Laparoscopic tools have been around for quite some time, but for the treatment of fibroids, a device that makes removing the fibroids laparoscopically is relatively new. Unfortunately, as great as a less invasive surgery sounds, questions regarding the safety and possible risk of harm to patients have been brought forward regarding this fibroid destroying device. This equipment is used nationwide, and women in Connecticut may be among those who have experienced negative consequences as a result of its use.

The power morcellator is a device used to essentially cut fibroids, breaking them down into smaller pieces, which allows physicians to remove them laparoscopically. This sounds amazing when compared to the risks of open surgery. However, no surgery, even those considered less invasive, are without risks. In a recent lawsuit brought against the manufacturer of the morcellator, a patient claims the use of this device is responsible for causing the spread of cancer and her need for extensive medical treatments.

Dissolution issue prompts recall of dangerous and defective drugs

In a recent report provided by the FDA, the recalls of three different drugs were announced due to dissolution issues. These dangerous and defective drugs were all recalled on a Class II status, meaning they could cause temporary issues, with a small chance of causing severe health consequences. All three drugs are distributed across the United States, and residents of Connecticut could be affected.

The first drug in question is produced by Caraco Pharmaceutical Laboratories, which is part of the Sun Pharma group. The recall pertains to ventafaxine hydrochloride, which is an antidepressant tablet. In total, 40,000 of the 30 and 90-count bottles have been included in this recall.

Manufacturer recalls some single-use vials of Warfarin

Bristol-Myers Squibb, also known as BMS, has issued a recall for some of their single-use vials of injectable Warfarin. The manufacturer claims the vials in question may contain particulates of both metallic and non-metallic matter, which could have potentially serious to fatal consequences. Residents of Connecticut who have the recalled product in their possession are encouraged to return the medication.

Warfarin is a popular brand of the blood-thinning product Coumadin. This recall is specifically for the injectable version of the drug which is freeze-dried and reconstituted with water before use; oral versions are said to be unaffected. The bottles in question were distributed to both pharmacies and hospitals from Nov. 2011 to Jan. 2014. In total, six lots of the single-use vials were recently recalled.

Gemcitabine recalled due to possibility of injury

Sun Pharmaceuticals has issued a voluntary recall of their cancer-fighting drug Gemcitabine. This recall was extended to U.S. markets and may affect cancer patients in Connecticut. Considering that chemotherapy patients already have enough to worry about between their illness and a weakened immune system, faulty chemotherapy drugs that may cause injury should not have to be another concern.

The FDA has marked this a Class II recall, meaning the suspected issue with the drug may cause temporary adverse medical effects. Though this recall only extends to a relatively small amount of this drug, 200 vials in total, this is still big news for the chemotherapy patients who may have come in contact with the product in question. According to Sun Pharmaceuticals, there may be an issue with the sterility of the product. The possible side effects of using the recalled bottles were not made available, and it is unknown if any patients have reported any issues with the drug.

Doctor's Best supplement recalled due to possible injury

Many people may or may not know that over-the-counter supplements are not subject to FDA approval before hitting shelves for consumption. As with most products, the belief that stringent testing is performed before allowing products to be sold can create a false sense of security. The simple truth is that supplements are not reviewed by the FDA until after adverse medical events or injury to users are reported. This knowledge should be cause for concern to individuals across the country, including residents of Connecticut.

A recent recall was issued for an over-the-counter supplement that is marketed to improve heart health. The manufacturer of Doctor's Best Red Yeast Rice has recalled 7,300 bottles of the supplement, stating these bottles could contain a prescription level cholesterol drug. The cholesterol medication, known as lovastatin, may have drug interactions if combined with other medications. Side effects may include muscle injury, liver injury and risks to pregnant women.

ConvaTec issues recall for defective medical devices

ConvaTec, the manufacturer of numerous medical devices used around the world, has issued a voluntary recall of one of its products. The recall comes after several facilities in the United States reported negative effects due to the use of the defective medical devices. In total, 13 events were reported, 12 resulting in serious injury to patients and one death. As this product is used nationwide, this recall could affect patients in Connecticut.

The device in question is the ConvaTec Flexi-Seal Control Fecal Management System Kits. This particular medical device is used by patients to regulate fecal incontinence and may also be used to give medications. Apparently, there has been an issue with the performance of the auto-valve feature. Complaints include that this feature has failed to perform its function consistently. There are many side effects of the device failure, which include rectal damage, leakage, skin deterioration and death.

Generic heart medication recalled, possibly improperly designed

A few generic versions of a popular heart medication, Toprol XL, were recently recalled from United States markets. As generics are often touted as being just as effective as brand name drugs and at a fraction of the cost, the distribution of the drug could affect patients from all over the country, including some heart patients in Connecticut. The recall was announced after it was learned that the drug may not adequately dissolve, possibly due to the medication being improperly designed.

Two manufacturers, Wockhardt and Dr. Reddy's Laboratories, both based in another country, issued recalls over the past two months regarding their generic forms of Toprol XL. This is a Class II recall, and it is believed to affect over 100,000 bottles of the heart medication. While that number is considered relatively small compared to the number prescriptions written for the drug, those who have been taking the medicine could experience adverse health problems.

Weight-loss supplements may harm users

As obesity rates continue to be a huge concern across the country, including in Connecticut, more products keep entering the market promising a quick fix. These weight-loss pills, typically available for purchase over-the-counter, are often touted as being healthy or all-natural, but the side-effects associated with these medications may actually cause harm to those choosing to take them. The real question here is should the makers of these supplements, who promise their products are safe and natural, be held accountable when adverse side-effects do result?

As these supplements do not require FDA approval before they hit the market, the number of these products available to the public has grown significantly over the years. In 1994, only 4,000 dietary supplements were available for purchase. Today, there are an estimated 85,000. This is a multi-billion dollar a year industry. Unfortunately, because of the variety of supplements available, the side-effects associated with these types of supplements can range in severity from mild to life-threatening.

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