Girardi | Keese

Compounding Pharmacies: FDA Inspection Leads To Recalls

In an indication of how much compounding pharmacies have taken advantage of the absence of regulatory oversight, a government inspection of a facility this week led to yet another product recall.

The U.S. Food and Drug Administration inspected Pallimed Solutions Pharmacy and the results were apparently not good. In fact, the company voluntarily undertook what it is calling an "aggressive precautionary recall measure" based on what its managers "observed" during the FDA's review of its operations. 

Pallimed Solutions sells a variety of products related to erectile dysfunction, including injection-based substances like testosterone. The recall affects 16 of its sterile compound products made or dispensed since January 1, 2013. On top of this recall, Pallimed also agreed to suspend its compounding work. It is not clear what inspection results prompted these steps.

Compounding pharmacies are likely to remain in the spotlight as more and more concerns come to light. This is just the latest scandal since the massive fungal meningitis outbreak attracted public attention to pharmacies like Pallimed last fall. Like the pharmacy responsible for that outbreak, Pallimed could be subject to product liability claims for selling defective products.

Source: Reuters, "Inspection yields another compound pharmacy recall," Mar. 25, 2013

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