Two more compounding pharmacies have recalled some of their sterile drugs from the market after the FDA expressed concern about manufacturing hygiene and sterility assurance.
Following a spate of recalls from U.S. compounding pharmacies, the U.S. Food and Drug Administration has announced that two more centers will be recalling their medicines from the market.
The first company is Pentec Health Inc. Pentec has initiated a limited, voluntary recall of in-date nutritional prescriptions for renal patients due to lack of sterility assurance. The recall is precautionary since Pentec Health has received no reports of injury or illness associated with any of the prescriptions subject to this recall.
The renal therapies were supplied to renal dialysis centers and directly to patients. Pentec Health has notifying each dialysis center and in-home dialysis patient of the recall.
The second company is NuVision Pharmacy Dallas Facility. The [url=http:// http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm352949.htm t=_blank]recall has come about because FDA investigators observed poor sterile production practices that raised concerns about a lack of sterility assurance of the company’s sterile drug products.
The Digital Journal has run a series of investigative articles on the crisis facing U.S. compounding pharmacies as the U.S. Food and Drug Administration (FDA) embarks on a series of inspections into issues of quality and sterility of medicines.
These different events, in short time frame, suggest that the continuing problems with quality control in certain U.S. pharmacies continues to be an issue of major concern, especially in relation to the potential risks of microbiological contamination
Read more: http://www.digitaljournal.com/article/350436#ixzz2To1toiiY
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