Category Archives: Defective Products

Does the FDA Report All Drug Recalls?

Drugs that have been improperly sterilized, incorrectly labeled or those that have failed to meet national drug standards are all eligible to be recalled, by either the Food and Drug Administration (FDA) or the drug manufacturers themselves. Class I recalls are the most serious, where a defective drug could reasonably cause serious or fatal health problems. Class II recalls may cause temporary or reversible health issues, but they can also cause secondary infections or complications with drug interactions. Between 2004 and 2011, the FDA failed to report as much as 40 percent of all Class I drug recalls, which are the most dangerous. The FDA’s two systems of recall notification, MedWatch and the FDA’s Recall Alert System, have an overall failure rate of between 20 and 40 percent. There is no federal law compelling pharmaceutical companies to disclose which drugs have been recalled, so consumers must rely on the FDA…
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FDA Shuts Down Drug Facility Due to Unsanitary Conditions

Unique Pharmaceuticals is recalling all non-expired sterile drug products due to concerns about sterility. The Food and Drug Administration (FDA) asked Unique to issue the recall after an inspection of the Unique Pharmaceuticals facility uncovered problems that could put patients at “an unacceptable risk for serious infection.” The agency was forced to question the sterility of all drugs produced at the facility when it discovered “unsanitary conditions,” including: sterility failures in several lots of drug products recurring environmental contamination problems poor sterile production practices According to a statement published on Unique’s website, the recalled products includes all non-expired, supposedly sterile drug products. The company warns that administering a contaminated product may result in life-threatening infections or death. Unique advises healthcare providers to check their medical supplies immediately and quarantine any of their sterile drug products. At the request of the FDA, Unique Pharmaceuticals has agreed to suspend all sterile compounding…
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Sun Pharmaceuticals Recalls Antidepressant

Sun Pharmaceutical Industries Ltd, an India-based drug manufacturer, is voluntarily recalling more than 40,000 bottles of a common antidepressant after it failed to meet dissolution standards. Venlafaxine hydrochloride, more commonly known as Effexor, is used to treat adults suffering from major depressive disorder, social phobias and general anxiety and panic disorders. Like most antidepressants, Effexor works by increasing concentrations of serotonin and norepinephrine in the brain. When a drug undergoes performance testing, dissolution standards help inspectors determine how effective it will be in the body. Drugs that fail dissolution tests could dissolve too slowly to be effective, or too quickly, overwhelming the patient’s system. Sun Pharmaceutical voluntarily issued the recall in June. The Food and Drug Administration (FDA) classified the preventative measure as a Class II recall, meaning that the drug’s defects could cause temporary or medically reversible health problems. The Indian drug manufacturer has suffered several setbacks this year….
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