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Balanced Solutions and Nora Apothecary recall products (updated)

By Tim Sandle     Apr 22, 2013 in Health
Balanced Solutions Compounding Pharmacy, LLC has announced a voluntary recall of all lots of sterile products compounded by the pharmacy that are not expired. The pharmacy joins a growing list of pharmacies recalling products across the U.S.
Several U.S. pharmacies have announced recalls of their medicinal products intended to be sterile during 2013. The list includes Green Valley Drugs, NuVision Pharmacy, ApothéCure, Inc., Med Prep and Clinical Specialties.
This is in addition to the now somewhat infamous New England Compounding Center incident, which led to several deaths due to a contaminated injectable steroid. According to the U.S. Centers for Disease Control, the case count stands at 733 people, across 20 U.S. states, and there have been 53 deaths.
To add to these recent recalls, the U.S. Food and Drug Administration (FDA) reports that Balanced Solutions Compounding Pharmacy, LLC is to recall its products from the market. This is due to concerns associated with quality control processes, which present a lack of sterility assurance. Patients are at increased risk for infections in the event a sterile product is compromised. The products were supplied to the offices of licensed medical professionals and patients. A full list of the affected products has been posted by the FDA.
Balanced Solutions Compounding Pharmacy, is a division of Axium Healthcare Pharmacy of Lake Mary, Florida. According to the Washington Post, the FDA are not aware of any illnesses amongst patients and that the recall is precautionary.
This is due to, ABC News notes, the FDA detecting unknown black particles in some product vials and, through testing, finding Gram-negative bacteria in products intended to be sterile.
As an update, the FDA announced on April 23 that Nora Apothecary & Alternative Therapies has announced a voluntary multi-state recall of all sterile drug products compounded by the pharmacy that have not reached the expiration date listed on the product. The recall is being initiated due to concerns associated with quality control processes that present a lack of sterility assurance and were observed during a recent FDA inspection.
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 risks of microbiological contamination. The Digital Journal will continue to monitor and report on the situation.
More about Pharmacies, Pharmaceuticals, Recalls, Contamination, Sterile
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