Welcome to Franck's

Franck’s Compounding Pharmacy is committed to patient safety. Recently, Franck’s initiated several changes and revisions, as necessary, to its already high standard processes, sterile compounding procedures and training and monitoring procedures. The company has highly qualified pharmacists overseeing and operating the compounding laboratory. Additionally, a new pharmacist has been recruited in Franck’s Quality Assurance Department to further monitor compliance with United States Pharmacopeia (USP) standards and Paul Franck, R.Ph., FIACP, President of Franck’s, continues to recruit additional qualified pharmacists and continues to directly seek enhancements to Franck’s operations and Quality Assurance.

These actions follow an extensive internal investigation to determine the root cause of the contamination of certain lots of intravitreal Brilliant Blue G (BBG), intravitreal Triamcinolone (TMC) and formulations containing Triamcinolone (Avastin/TMC) that the company recalled in March as a precautionary measure.

To aid in the internal investigation, Franck’s Pharmacy hired independent testing laboratories, consultants experienced in sterile compounding and pharmacy processes, and additional third parties. The investigation successfully determined the root cause of the contamination of the BBG and TMC products involved. Franck’s Pharmacy remains confident that the findings have accurately identified the cause and that the issues are now resolved.

Franck’s cooperated fully with both the Florida Department of Health and the U.S. Food & Drug Administration to conduct the product recalls and during post-recall inspections in an effort to isolate the source of contamination and prevent future occurrences.

One of the nation’s largest compounding pharmacies, the Florida-based Franck’s Compounding Pharmacy has been recognized nationwide for exceptional standards in the art of custom compounds for people and companion animals. In 2012 Franck’s Pharmacy will celebrate 29 years of nationwide service.

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March 9, 2012

Dear Physician:
Our records indicate that your office received Brilliant Blue G compounded at Franck’s Lab. We have recently received reports that some patients treated with Brilliant Blue G have experienced fungal infections in the eye. The origin and cause of these eye infections has not yet been determined. The following lots of Brilliant Blue G are suspected of fungal contamination:

• 08232011@80
• 10132011@6
• 10112011@82
• 10192011@125

As a precautionary measure and to prevent any additional risk of eye infections in patients, we are recalling all Brilliant Blue G compounded by Franck’s Lab. You are requested to immediately quarantine and return to us any remaining Brilliant Blue G product you may still have. This includes ALL LOTS of Brilliant Blue G that you have received from Franck’s Pharmacy. Our accounting department will issue credit on receipt of product.

Please complete the recall response form and return the product to the address below with the postage provided. If you would like to report any adverse events, or if you would like to receive additional information regarding this product recall, please contact us Monday through Friday, 8 a.m. to 5 p.m., at 352-622-2913 ext. 209 and request the Pharmacist-in-Charge.

Regards,
Jim Kilbride, RPh
Pharmacist-in-Charge
Franck’s Compounding Lab
1210 SW 33rd Ave. Ocala, FL 34474
352-622-2913
Fax: 352-690-6770

May 2, 2012

Dear Physician,

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.

Regards,
Jim Kilbride, RPh
Pharmacist-in-Charge
Franck’s Compounding Lab
1210 SW 33rd Ave. Ocala, FL 34474
352-622-2913
Fax: 352-690-6770