More Drug Compounding Recalls for Bacteria in Vials of Product
April 22nd, 2013 // 5:11 pm @ jmpickett
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A drug compounding firm in Tennessee is doing a voluntary recall of its entire line of sterile injectable drugs. This happened after FDA cGMP inspectors discovered strong evidence of bacterial contamination in vials of finished products.
The recall was announced by FDA for Balanced Solutions Compounding, which is based in Lake Mary FL. One of the products that is being recalled is methylprednisolone acetate vials. This is the same type of steroid for the spine that caused a national fungal meningitis scare that killed 50 citizens, including 15 in Tennessee.
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During the cGMP inspection, FDA investigators found poor conditions and GMP practices during an inspection of the plant. Tests showed there was strong evidence of gram negative bacteria in chromium chloride, which is an injectable drug made by the firm. FDA stated that its early findings on the company’s sterile production routines and the conditions at the site raised strong concerns about poor sterility.
FDA did note that the type of bacteria that was found during the FDA audit was sphingobacterium thalpophilum, and this usually does not cause illness in humans.
The drug in question in this recall is usually given as a supplement to patients who are being fed intravenously.
This recall came just as FDA is ramping up its inspection and enforcement for drug compounding companies. A total of 52 sterile drug products are subject to this recall, FDA noted.
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