GIRARDI KEESE LAWYERS
Take Action Today 800-401-4530

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

No Comments

Leave a comment
Comment Information

DISCLAIMER: Case results depend upon a variety of factors unique to each case. Case results do not guarantee or predict a similar result. Any testimonials and endorsements at this site do not constitute a guarantee, warranty, or prediction regarding the outcome of your legal matter or potential legal matter.

Email GK Today!

Contact for a Free Case Evaluation

Bold labels are required.

Contact Information
disclaimer.

The use of the Internet or this form for communication with the firm or any individual member of the firm does not establish an attorney-client relationship. Confidential or time-sensitive information should not be sent through this form.

close

Privacy Policy