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Another Compound Pharmacy Recall Due to Contamination Issues
The U.S. Food and Drug Administration (FDA) recently issued a warning to physicians across the country not to use any compounded drugs that were manufactured by Unique Pharmaceuticals because of possible contamination. This action was done in response to an FDA inspection of the company's Temple, Texas manufacturing plant, where inspectors found issues with medication production that may have compromised the sterility of the medication.
Unique Pharmaceutical issued a voluntary recall of all its sterile compounded medications that have not yet expired and are advising that all products be returned to the company. The products were contained in vials, bags and syringes. Non-sterile items manufactured by the company are not affected by the recall. In the warning to consumers, the FDA said that patients who use sterile items that may have been contaminated are at risk of serious and possibly fatal infections.
Compounding pharmacies manufacture customized medications that have been ordered by doctors. According to the International Academy of Compounding Pharmacists (IACP), out of the almost 56,000 compounding pharmacies in the country, approximately 7,500 offer “advanced compounding services.” About 3,000 of them manufacture sterile products.
However, many of these companies have come under federal scrutiny after a 2012 fungal meningitis outbreak occurred that was traced to contaminated medications sent throughout the country by New England Compounding Center (NECC). Over 14,000 patients were given the contaminated medication. There were 751 cases reported and 64 deaths.
At the time of the incident, compounding pharmacies fell under the jurisdiction of state pharmacy boards and not under the more stringent guidelines of the FDA. But Congress changed that after the 2012 incident. Under the FDA, there have been multiple recalls of compound drugs due to contamination issues.
If you have suffered complications or injuries from a defective drug, contact an experienced Crystal Lake defective drug attorney to find out what compensation you may be entitled to for pain and loss.