FRANCK’S PHARMACY RECALLS ALL STERILE HUMAN AND VETERINARY PRESCRIPTIONS FROM NOV 21, 2011 TO MAY 21, 2012

ENVIRONMENTAL SAMPLING OF CLEAN ROOM REVEALED PRESENCE OF MICROORGANISMS AND FUNGAL GROWTH BY FDA.  WHAT HAPPENED TO USP <797>?

Franck’s Pharmacy, Ocala, Florida initiated a recall of all sterile human and veterinary prescriptions from November 21, 2011 through May 21, 2012.  This recall follows an earlier recall (May 2, 2011 Notice of Recall, Triamcinolone acetonide) wherein the lab experienced a fungal issue as well as a recall of all lots of Brilliant Blue G (March 9, 2012 for fungal endophthalmitis).

USP revised <797> “Pharmaceutical Compounding – Sterile Preparations ” in 2008 regarding compounding pharmacies wherein it prescribes various environmental controls that should be maintained when manufacturing and filling aseptic products.  Included within this monograph are recommendations for an “Environmental Viable Airborne Particle Testing Program” which includes 1) an appropriate sampling plan, selected sampling sites for each ISO 5, 7 and 8 areas, 2) method of collection, 3) frequency of sampling, 4) volume of air sampled, and 5) Action Levels.  The document also encourages that competent microbiology personnel shall be consulted if an environmental sampling consistently shows elevated levels of microbial growth.  The growth of fungi over a prolonged period of time suggests that the firm should reevaluate the adequacy of personnel work practices, cleaning procedures, operational procedures and air filtration efficiency within the aseptic compounding location.

Several of the recalls are summarized below:

Recall of March 9, 201 for Brilliant Blue G (BBG)

ISSUE: FDA has received reports of fungal endophthalmitis (eye infections) in patients who were given Brilliant Blue G (BBG), supplied by Franck’s Pharmacy, during eye surgeries. Clinicians in several states reported the adverse events. FDA, along with CDC and local and state public health agencies, are actively investigating these adverse events.

BACKGROUND: The BBG was supplied by Franck’s Compounding Lab, Ocala, Florida. Franck’s Pharmacy issued a recall on March 9, 2012, of all lots of Brilliant Blue G and issued a recall letter (link below). Brilliant Blue G is not an approved drug in the U.S.

RECOMMENDATION: Immediately quarantine and return any remaining Brilliant Blue G product from Franck’s Compounding Lab. This includes all lots of Brilliant Blue G received from Franck’s.

FDA requests that practitioners report to MedWatch any cases of endophthalmitis, fungal or bacterial, that occurred within the last six months, associated with eye surgery in which Brilliant Blue G from any source was used.

Recall of March 29, 2011 for Triamcinolone Acetonide

Franck’s lab recently had a fungal issue with one lot of triamcinolone acetonide P.F. 80mg/ml and on March 29, 2011 instituted a recall. The recall involved five physicians and eight prescriptions. The physicians have been contacted and all prescriptions accounted. As a precaution Franck’s Lab has recalled one additional lot of triamcinolone acetonide P.F. 80mg/ml. No adverse events have been reported related to this lot. The recall involved four physicians and five prescriptions. All offices have been contacted. If you have any concerns or questions regarding a prescription of triamcinolone acetonide or product containing triamcinolone acetonide received from Franck’s do not hesitate to contact us.

Recall of May 25, 2011 for All Sterile Human and Veterinary Prescriptions Distributed by Franck’s Pharmacy From November 21, 2011 to May 21, 2012.

This recall is being initiated after the U.S. Food and Drug Administration (“FDA”) notified us that environmental sampling of our clean room revealed the presence of microorganisms and fungal growth. 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. Accordingly, we are extending the recall to all sterile preparations we have provided to you 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.

FDA will expect us to be able to account for all of the sterile preparations subject to this recall. As a result, it is critically important that you read, complete, and return the enclosed response form as soon as possible.