Sterile medical devices and products should be free from any life form, such as bacteria or viruses. Sometimes, that is not the case and adverse reactions occur from non-sterile medical products. For instance, a few months ago The Food & Drug Administration discovered gram-negative bacteria in a chromium chloride injection, prompting the manufacturer, Balanced Solutions, to recall all of its non-expired sterile products. Similarly, this week Specialty Compounding is recalling all lots of sterile medications due to reports of bacterial infections.
According to a press release, the recall was prompted by reports of bacterial infections in 15 patients in Corpus Christi, Texas. The patients had received IV infusions of calcium gluconate at two hospitals. In the press release, Specialty Compounds states that “there is a potential association between the infections and the medication at this time.” According to USA Today, the infusions can be used as part of the treatment of cardiac arrest. Additionally, calcium deficiency and extremely high potassium levels can be treated with the infusions.
When products that are meant to be sterile contain microbial contamination, patients can develop serious infections that can be life threatening. Since last September’s outbreak of fungal meningitis, the FDA has increased inspections and the media and public have placed increased scrutiny on pharmaceutical companies. 63 people died and 749 people developed an illness due to last year’s outbreak, which was “caused by steroid injections from the New England Compounding Center in Massachusetts.”
Specialty Compounding’s recall applies to all unexpired sterile compounded units that were distributed since May 9. The recall includes all strengths and dosage forms of the units. The products were distributed at hospitals and physician offices in Texas, and were also sent to patients’ homes in all states except North Carolina.
The company is informing consumers about the recall via phone, email, fax and/or regular mail. Specialty Compounding urges people who use or have received any affected products to immediately discontinue the use of the products and return them to the company. Consumers can contact Specialty Compounding at 512-219-0724 weekdays from 10 a.m. to 5 p.m. CDT.
It goes without saying that flawed medications are often very dangerous for consumers. Earlier this month, a large drug product manufacturer, Fresenius Kabi, recalled four lots of Benztropine Mesylate Injections due to the risk of tiny clear particulates existing in the glass vials, posing a safety risk to consumers. This week, another large drug manufacturer issued a recall for a defective medical product. Read more
Although hip replacements can often help individuals live with their disabilities, some products can lead to serious health complications and can put the patient in danger. Compared to older ceramic and plastic models, the metal-on-metal models were supposed to be more stable, less prone to dislocation, and longer-lasting. However, two popular hip replacement manufacturers, Stryker Corporation and DePuy Orthopedics, issued recalls within the last few years for metal-on-metal devices due to high early failure rates and serious health effects. Read more
Last October, the New England Compounding Center of Massachusetts was declared responsible for distributing more than 17,000 single-dose steroid injections that were ultimately responsible for a fungal meningitis outbreak that resulted in 50 deaths throughout the country. Read more
For the past two weeks, the U.S. Food and Drug Administration and state health agencies throughout the country have been working diligently and vigorously to put an end to a fungal meningitis outbreak that was initiated by thousands of tainted steroid injections. In the days after the outbreak was reported, dozens of people were confirmed ill and five people have died as a result of contracting meningitis from the injections. Read more
The Food and Drug Administration (FDA) recently announced the voluntary recall of two different types of Pfizer oral contraception tablets after the manufacturer found that some packs of the medication may contain the wrong number of inert or active ingredient tablets and that they may also be packaged out of sequence. Read more
DePuy Orthopedics, a subsidiary of pharmaceutical and chemical company Johnson & Johnson, may be held responsible legally and financially for tens of thousands of hip revision surgeries, the UK Daily Mail reports. The company sold 93,000 hip replacement devices between 2003 and August 2010, when the company instituted a recall. Out of those 93,000 devices, about 12 percent will probably fail, according to a Fox News article. Read more
Jacqueline Lum of Honolulu, Hawaii received a DePuy ASR Acetabular hip replacement system implant in August, 2009. Only 15 months later, Lum suffered constant pain from the defective device as it ground together and deposited toxic metal fragments into her bloodstream, a Hawaii News Now article reports. Lum was scheduled to undergo revision surgery on November 8, 2010. Read more
In the midst of all the legal reports and descriptions of symptoms experienced by patients in class action and multi-district litigation suits against DePuy Orthopedics, individual patient experiences can get lost in the shuffle. However, it is this personal suffering that led to the lawsuits in the first place. While important to stay aware of the larger issue, DePuy must be held accountable for the suffering caused by its devices. Read more
At the March, 2010 conference of the American Academy of Orthopedic Surgeons, two knee surgeons reported implant surgery findings of the Zimmer NexGen knee replacement system, according to the organization’s site. Of those surgeries, the site reports that 36 % of those implants were loose while 9.3% “had revision or impending revision for painful loosening.” Of those 146 surgeries the pair of doctors detailed at the conference, 108 were shown to have some form of complication later. Read more