Compounder recalls 6 months of prescriptions
Posted June 20, 2012
A Florida drug compounder issued a recall for all of its sterile animal- and human-use products distributed during a six-month period.
Franck’s Compounding Lab announced in late May that environmental tests of the company’s clean room by the Food and Drug Administration were positive for microorganisms and fungal growth, and the company was recalling all sterile preparations distributed from Nov. 21, 2011, through May 21, 2012.
“In light of the FDA’s findings and the resulting possible risk of infection, we have decided that it is imperative that we recall all human and veterinary sterile preparations that have left our control,” the company said.
The notice indicates physicians should review and evaluate patient records to determine whether adverse events could have resulted from use of the recalled products.
Franck’s and the FDA also are opposing parties in a dispute in the 11th U.S. Circuit Court of Appeals. The FDA filed the appeal after a district court judge ruled that the agency had overreached in interpreting its authority over animal drug compounding and denied an FDA request for an injunction against Franck’s and its owner, Paul W. Franck.
The FDA has accused Franck’s of manufacturing animal drugs under the guise of traditional pharmacy compounding.
Previous court filings indicate Franck’s filled about 37,000 animal drug prescriptions during 2009, but three documents indicate that this was the number of prescriptions filled in 10, 11, or 12 months.