Regulatory Focus™ > News Articles > Franck's Pharmacy Issues Extensive, 'Urgent' Recall After Facility Contamination

Franck's Pharmacy Issues Extensive, 'Urgent' Recall After Facility Contamination

Posted 24 May 2012 | By Alexander Gaffney, RAC 

Pharmaceutical compounder Franck's Pharmacy issued what it called an "urgent" recall of all of its sterile human and veterinary products after an inspection by the US Food and Drug Administration (FDA) found fungal growth and microorganisms in a supposedly sterile room.

"In light of the FDA's findings and the resulting possible risk of infection, we have decided that it is imperative that we recall all human and veterinary sterile preparations that have left our control," wrote Franck's in a letter posted to both its website and FDA's website.

The recall extends back to all affected products compounded by Franck's after 21 November 2011.

"FDA will expect us to be able to account for all of the sterile preparations subject to this recall," explained Franck's in its statement. "As a result, it is critically important that [users and physicians] read, complete, and return the enclosed response form as soon as possible."

Read more:

Franck's Compounding Pharmacy - Urgent: Compounded Prescription Recall

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