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Environmental sampling by the FDA of the Franck's Compounding Pharmacy clean room revealed the presence of microorganisms and fungal growth. In light of the FDA’s findings and the resulting possible risk of infection, Franck's has recalled all human and veterinary sterile preparations that have left their control as well as all sterile preparations provided since November 21, 2011.
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.
This recall should be carried out to the User/Physician level. Your assistance is appreciated and necessary to prevent patient illness. Physicians should be advised to review and evaluate their patient records to determine if any adverse events may have resulted from use of the recalled products. Please report any adverse events to Franck’s Compounding Pharmacy and FDA’s MedWatch program.
Adverse reactions or quality problems experienced with the use of this product/lot may be reported to the FDA’s MedWatch Adverse Event Reporting program online, by regular mail, or by fax.