Franck's Recalls All Sterile Human and Veterinary Prescriptions Distributed From November 21, 2011 to May 21, 2012

Topics: Patient safety

Franck’s Compounding Pharmacy has initiated a recall of all sterile preparations provided from November 21, 2011 to May 21, 2012. Franck’s initiated the recall after FDA notified the pharmacy that an environmental sampling of its clean room revealed the presence of microorganisms and fungal growth. In an alert posted on the FDA Web site, Franck’s advises that “if any of these sterile preparations remains under your control, it is essential that you do not use them and that employing appropriate practices, you destroy all such sterile preparations and all remaining portions of such sterile preparations.” Any related adverse events should be reported to FDA’s MedWatch program by completing the online form. A May 4, 2012 Centers for Disease Control and Prevention report indicated that there were 33 cases in seven states of confirmed or probable eye infections following use of products prepared by Franck’s Compounding Lab. Information on prior related recalls is available on the FDA Web site.