Pharmco Laboratories
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SkinCare Co. Pharmco Laboratories Receives Warning From FDA

Pharmco Laboratories received a warning letter from the FDA citing 4 violations.

Pharmco Laboratories received a warning letter from the Food and Drug Administration. The letter to the Florida-based skincare manufacturer “summarized significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals.”

In the letter posted to the agencywebsite, four specific violation were referenced.

Pharmco Laboratories was accused of presenting an allergy risk to consumers. The FDA states that there has been insufficient evidence of the proper cleaning of equipment that came in contact with major allergens. Dietary supplements, for example, containing soybeans used the same dryer as the ingreditents in skincare items.

The FDA warning letter stated that “repeated lapses demonstrate a failure of your executive management to exercise proper oversight and control over the manufacture of drugs.”

Powdered medical gloves
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Powdered Medical Gloves Banned By the FDA

The use of most powdered medical gloves has been banned by the FDA.

For only the second time in history the FDA has banned a medical device. Powdered medical gloves seem to pose adverse risks.Powdered medical gloves

The Food and Drug Administration (FDA) has found that powdered medical gloves (powdered surgeon’s gloves, powdered patient examination gloves, and absorbable powder for lubricating a surgeon’s glove) “present an unreasonable and substantial risk of illness or injury.” This has led to a new rule banning these products from use, effective January 18, 2017.

One group has called the ban “18 years too late.” Nearly 20 years ago, in 1998, the advocacy group Public Citizen, filed the first of several citizen’s petition calling on FDA to ban powdered gloves.

After the ban was proposed by the FDA, Public Citizen responded saying that “when a medical product, drug or, in this case device, has unique serious risks but no unique benefit, it should be banned. The FDA’s statement that “we … only take this action when we feel it’s necessary to protect the public health” ignores overwhelming evidence going back almost two decades about the necessity to do so.”

Back in March of 2016, the FDA had prosed the powdered medical gloves citing evidence that they were a  danger to  patients, risks included airway and wound inflammation, post-surgical adhesions and allergic reactions.

Powdered gloves aim to make the removal of gloves easier for medical professionals. So, the FDA had to determine whether the ease of use outweighed the risks.

The rules not that powder is fine when used in the manufacturing process, but should not be a part of the finished product. The rule from the FDA “encourages manufacturers to ensure finished non-powdered gloves have as little powder as possible.”

 

If you believe that you or a loved one might have suffered from the medical use of powdered gloves, let the Medical Claim Legal Team help.

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Oatmeal lawsuit goes class action, glyphosate found

The worst thing ever would be if the stuff that is supposed to be good for you actually wasn’t good for you–and could actually kill you. While the New York Post isn’t exactly known for their patience, they did decide to use the headline “Your Oatmeal May Be Killing You” after reports came out in the New York Times New York Times stating that testing found traces of “glyphosate in some Quaker Oats oatmeal.” Thus begins the so-called “Oatmeal Lawsuit.”

oatmeal lawsuit
Glyphosate reportedly found in oatmeal; used as a herbicide

For those that don’t know, glyphosate is a harmful chemical and can kill you in mass quantities. According to the article in the Times, the chemical was “detected in the oatmeal falls well below the limit set by federal regulators for human consumption….Since oats require less herbicide spray than many other grains, there is less risk of pollutants and groundwater contamination.” The result of this is the “oatmeal lawsuit, “a class-action claim where the plaintiff is seeking $5 million in damages, according to the New York Post. The claim points out that the “100% Natural” claim is actually “‘false, deceptive and misleading,’ because the company uses…glyphosate in processing its oats.”

Obviously this case falls under a number of areas and will be interesting to watch from a product liability and false advertising level. Additionally, the presence of a harmful chemical could bring other agencies and regulatory groups into the mix. This venerable company, founded by Ferdinand Schumacher in Akron, OH in 1850 has certainly been around for awhile and has seen worse–but it certainly can’t exactly help their image and their market share in the ever-growing oatmeal market.