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Franck?s Compounding Pharmacy in Ocala, Fla., announced today that it is recalling all sterile human and veterinary prescriptions that is distributed from November 21, 2011, to May 21, 2012.
Franck’s Compounding Pharmacy in Ocala, Fla., announced last week that it is recalling all sterile human and veterinary prescriptions that is distributed from November 21, 2011, to May 21, 2012.
Paul Franck, president and CEO, said in a new release that the company initiated the recall after an FDA environmental sampling of Franck’s clean room revealed the presence of microorganisms and fungal growth.
FDA reported that it is notifying all physicians and medical care organizations who have ordered any compounded product sold as a sterile preparation by Franck's of the recall.
“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,” Franck’s advised customers.
The company advised physicians to review and evaluate patient records to determine if any adverse events may have resulted from use of the recalled products. Adverse events should be reported to FDA’s MedWatch program.