Pharmacy Services
Franck's Compounding - All Sterile Preparations - Do Not Use
May 25, 2012
FDA has expanded their previous warning for Brilliant Blue G and Triamcinolone from Franck’s Compounding to include all sterile products. Due to the potential for contamination, the recall is extended to all human and veterinary sterile products supplied from Franck’s Compounding since November 21, 2012. These products must not be used.
On March 19, 2012, FDA, Centers for Disease Control and Prevention (CDC), and local public health agencies reported that they were investigating reports of fungal endophthalmitis in patients who received Brilliant Blue G (BBG) during eye surgery. Since the initial report, additional fungal endophthalmitis cases have been reported with Brilliant Blue G as well as triamcinolone acetonide 80 mg/mL preservative-free ophthalmic injection supplied by Franck’s Compounding Lab. Brilliant Blue G is not FDA approved for use in the United States. Franck’s Pharmacy is recalling ALL lots of Brilliant Blue G and 2 lots of triamcinolone acetonide. Initially, Franck’s had recalled 1 lot of triamcinolone acetonide; however, a second lot was recalled in May, 2012. Healthcare professionals should not use any product received from Franck’s since November 2011.
Report any related adverse events, including cases of fungal or bacterial endophthalmitis, occurring within the last six months to FDA’s MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch/HowToReport/DownloadForms/default.htm). The recalled lot numbers and instructions for returning affected product are available in the links below.
Additional information is available at the following links:
- Medwatch Alerts:
- May 25, 2012:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm305592.htm - May 4, 2012:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/ SafetyAlertsforHumanMedicalProducts/ucm296383.htm - April 20, 2012:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/ SafetyAlertsforHumanMedicalProducts/ucm301137.htm - March 19, 2012:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/ SafetyAlertsforHumanMedicalProducts/ucm296383.htm
- May 25, 2012:
- CDC Morbidity and Mortality Weekly Report, May 4, 2012:
http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6117a5.htm?s_cid=mm6117a5_w. - FDA Press Release, May 25, 2012:
http://www.fda.gov/Safety/Recalls/ucm305509.htm - FDA Press Release, May 2, 2012:
http://www.fda.gov/Safety/Recalls/ucm302899.htm - Updated FDA Warning Statement, April 20, 2012:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm301137.htm - FDA Warning Statement to Physicians, March 19, 2012:
http://www.fda.gov/Drugs/DrugSafety/ucm296410.htm - Company Recall Letters:
http://www.francks.com/
Updated
May 25, 2012;May 4, 2012; April 23, 2012; March 20, 2012; University of Utah, Drug Information Service. Copyright 2012, Drug Information Service, University of Utah, Salt Lake City, UT.
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