Regulatory Focus™ > News Articles > Second Compounding Pharmacy Recalls all Products After Sterility Concerns Raised

Second Compounding Pharmacy Recalls all Products After Sterility Concerns Raised

Posted 21 March 2013 | By Alexander Gaffney, RAC

For the second time in a single week, a US-based compounding pharmacy has announced the recall of all of its compounded products, again due to contamination affecting supposedly sterile products.

The company, Georgia-based Clinical Specialties, issued a voluntary recall notice on 20 March 2013 indicating that all products manufactured by the company were at risk due to "lack of sterility assurance."

Similar problems have plagued the industry in recent months, starting in October 2012 with the recall of most products manufactured by the New England Compounding Center (NECC), whose products were blamed for a massive outbreak of fungal meningitis. Since then, state and federal regulators have inspected dozens of firms nationwide and sanctioned many of them, principally for sterility and quality issues.

Pharmaceutical compounding, unlike large-scale manufacturing, generally involves the production of numerous types of products in the same facilities. Whereas some facilities run dedicated and physically separate facilities for each line of products produced, many compounders will make numerous-if not dozens-of products inside the same room, if not under the same production hood. A lapse in sterility can therefore affect multiple products depending upon the manufacturing techniques used.

In the case of Clinical Specialties, problems first came to light when the Center for Disease Control and Prevention (CDC) notified the US Food and Drug Administration (FDA) of several eye infections associated with a compounded version of Avastin. At least five patients had been diagnosed with endophthalmitis-"a serious complication that can lead to permanent loss of vision"-after receiving a version of the drug compounded into single-use syringes by the company.

Clinical Specialties said that while, "There has been no evidence of contamination with sterile products other than the specified Avastin lots, [it] has decided in the interest of [its] patients to proceed with this recall process."

The recall affects more than 60 products produced by the company.

The recall, though extensive, is still smaller than another one initiated this week by Med Prep Consulting, another pharmaceutical compounder that initiated a total recall of its products after users noticed visible contamination in its products. The company's recall extends to 83 products, including sterile injectable drugs, pre-filled syringes, bags, pumps and vials.


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