Georgia Compounding Company Recalls Drugs, Second Recall this Week
A Georgia Compounding company is the latest culprit to recall drugs due to possible contamination. This is already the second recall within a week after a New Jersey compounding company recalled its products, and third within the last year. The Food and Drug Administration (FDA) prompted this recall because the FDA was concerned about the safety of the sterile products.
The Georgia company, Clinical Specialties Compounding Pharmacy based in Augusta, decided to recall all of its shipments of Avastin, a drug used to treat macular degeneration, which is an eye condition that tends to affect older people and can lead to blindness. This first recall from the company was followed by another one a few days later in which the company decided to recall all of its sterile products as well. Avastin was first recalled when five patients developed serious eye infections which were attributed to the vials of Avastin that the company had repackaged. The new packaging was a single use syringe that was stated to be sterile. The eye infections that the patients developed are known as endophthalmitis. The infection starts on the inside of the eyeball and can lead to blindness.
"Preliminary findings of practices at the site...raise concerns about a lack of sterility assurance," the FDA explained in regards to the later recall of all sterile items.
The frequency of these recalls at compounding pharmacies draws concerns over the safety of these products. Many of the experts feel that these recalls can be blamed on the poor enforcement of the FDA. The FDA is now currently working with the Centers for Disease Control and Prevention (CDC) to evaluate the extent of the damages caused by the company.
The first compounding company to recall its products dates back to September, in which a Massachusetts based company accidentally infected people with a rare strain of meningitis. The second compounding company recalled products due to mold contamination. The contamination did not afflict any one so far.
The recall included products that were distributed from Oct 19, 2012 to March 19, 2013.