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U.S. Department of Health and Human Services

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Updated: FDA Issues Second Warning to Physicians about Certain Compounded Drugs from Franck's


[04-20-2012]
  FDA has received additional reports of fungal endophthalmitis (eye infections) in patients who were given Brilliant Blue G (BBG) during eye surgery since the FDA Warning to Physicians was posted on March 19, 2012. The agency has also recently received reports of eye infections in patients who were given injections of drug products containing triamcinolone during eye surgery.

These drugs were supplied by Franck’s Pharmacy in Ocala, Florida. Brilliant Blue G is not an approved drug in the United States. Franck’s has recalled all lots of BBG and one lot of Triamcinolone Acetonide P.F. The Centers for Disease Control and Prevention (CDC) has advised healthcare personnel to stop use of all sterile triamcinolone-containing products purchased from Franck’s until further information regarding the safety of these products is available.

Clinicians in several states reported the adverse events.  FDA, CDC, and local and state public health agencies are actively investigating these incidents.

FDA requests that practitioners report to FDA any cases of suspected fungal or bacterial infections, which have occurred within the last six months, associated with drugs labeled as sterile from Franck’s Pharmacy. 

Reports should be sent to 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-0178

Franck’s Pharmacy issued a recall on March 9, 2012, of all lots of Brilliant Blue G. Franck’s issued a recall on March 31, 2012 of one lot of Triamcinolone Acetonide P.F.

Franck’s Recall Letters:
http://www.francks.com/
 
http://www.fda.gov/Safety/Recalls/ucm296326.htm