Franck’s Lab Brilliant Blue Recall

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Franck’s Compounding Pharmacy Sterile Preparations: Reports of Fungal Endophthalmitis, Expanded Recall 5/24/2012

AUDIENCE: Ophthalmology, Urology, Primary Care, Pharmacy

ISSUE: FDA is notifying all physicians and medical care organizations who have ordered any compounded product sold as a sterile preparation by Franck’s Compounding Pharmacy of Ocala, Florida, of the recall of all sterile products sold by Franck’s since November 2011 due to the possibility of lack of sterility.

BACKGROUND: The recall is being carried out to the user physician. An active investigation of this matter by the CDC and FDA is ongoing at this time. In March 2012, FDA 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. In April 2012, FDA received reports of eye infections in patients who were given injections of Franck’s drug products containing triamcinolone during eye surgery.

RECOMMENDATIONS: FDA advises that any product received from Franck’s since November 2011 not be used and customer/physicians follow the instructions provided by Franck’s. FDA also recommends that any adverse events suspected to be associated with use of the products be reported to FDA:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, including a link to the press release, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm305592.htm

Franck’s Compounding Pharmacy – Ongoing Investigation of Fungal Endophthalmitis Cases: CDC Recommendations

[UPDATED 05/04/2012] The Centers for Disease Control and Prevention (CDC) has advised healthcare personnel to avoid use of compounded products labeled as sterile from Franck’s during the ongoing investigation. Franck’s Lab has recalled one additional lot of triamcinolone acetonide P.F. 80mg/ml. The recall involved four physicians and five prescriptions.

[UPDATED 04/20/2012] FDA issues second warning to physicians regarding cvertain compounded drugs from Franck’s. FDA received reports of eye infections in patients who were given injections of drug products containing triamcinolone during eye surgery.

[Posted 03/19/2012]

AUDIENCE: Ophthalmology, Risk Manager

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.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178Read the

MedWatch safety alert, including a link to the Press Release at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm296383.htm

 

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