FDA Warnings

In today’s modern world, we rely on the integrity of the pharmaceutical industry to maintain safe, effective medications. We envision a lab of dedicated scientists working tirelessly to solve the illnesses that rob us of our quality of life. For the most part, that is probably accurate. Most of the drug companies are spending money and searching for the latest cure-alls sure to be safer and more reliable than the kitchen sinks cures of yesteryear. However, sometimes mistakes are made, or greed gets in the way of conscience and a drug is marketed to a trusting public that may cause more harm than good.

The FDA is Responsible for Protecting the American Public

The U.S. Food and Drug Administration (FDA) has been charged with safeguarding the American consumer’s trust that the products developed can be used safely and as marketed by the drug manufacturers.

The job of ensuring that the American public has access to safe, reliable pharmaceuticals is not an easy task, and is in fact, a global responsibility According to the FDA, around 80% of active ingredients in our medications are manufactured outside our country.  Prescription drug imports have been increasing almost 13% yearly.  Manufacturers are under pressure to produce at the lowest cost possible while improving productivity which means more for the FDA to regulate.  Is it no wonder then, that sometimes a drug is marketed that may either not be as effective as hyped or even could cause harm to some individuals. The FDA releases warnings and recalls whenever their research data indicates a potentially dangerous situation.

At D. Miller & Associates, we believe that everyone deserves to know exactly what to expect from an approved product. Consumers that have been mislead or harmed after using a medication or product as approved should have a legal claim for compensation.

FDA Warning Letters

The FDA will often receive notice about a potential problem either from the company itself, through inspections, from adverse event reports from consumers, and through the Center for Disease Control (CDC).

Whenever a violation is then confirmed by the FDA, they may send a warning letter to the company or individuals responsible for the product giving them the opportunity to correct the issue without an enforcement action. The warnings are handed out with the expectation that the violation will then be voluntarily corrected in order to comply with the Federal Food, Drug, and Cosmetic Act.

These letters are only sent in the case of significant violations. If the proper action is not taken, it could result in furthers actions such as recall, seizure, injunctions, penalties or prosecution.

The FDA is warning about potential safety problems at over 30 specialty pharmacies.


April 16, 2013 -ApothéCure, Inc., Clinical Specialties Compounding Pharmacy (CSCP) and NuVision Pharmacy are voluntarily recalling all lots of sterile products compounded and distributed by these specialty pharmacies. This recall comes after the U.S. Food and Drug Administration (FDA) inspected 31 compounding pharmacies and found a lack of sterility assurance and concerns associated with the quality control processes. Inspections were conducted at locations in 18 states, including Florida, Arizona, and New Jersey.

The inspections were ordered after a meningitis outbreak last summer brought on my steroids distributed by the New England Compounding Center. The tainted medication caused the deaths of 51 patients and over 730 others became sickened.

According to the FDA, violations found during the inspections included rust and mold in rooms used to package injectable drugs, black particles in the medication, and workers handling sterile products with their bare hands and wearing non-sterile lab coats.

The FDA is asking that anyone who has received any product from these pharmacies and are concerned should contact their health care provider. If you have been injured as a result of any compound medication, please contact us with your information.

 

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