Those persons who follow recall information regularly likely heard recently about a recall involving certain products that had been manufactured at a place called Franck’s Pharmacy. Now, that same company is issuing another recall.
This time, the recall affects every single sterile human or veterinary prescription that Franck’s distributed between November 21 of last year and this past Monday. The company is requesting that everyone with any such sterile preparation in their possession destroy it immediately according to mandated guidelines. Anyone affected by the recall is being urged by Franck’s to fill out a response form and send it to them so that they can account for each sample being recalled.
The Food and Drug Administration discovered that the clean room used by Franck’s in preparing drugs tested positive for fungal growth and the presence of various microorganisms. Because of the immediate hazard that such a situation can create, Franck’s is asking all doctors to look back over their patient records if a patient under their care had been given one of the recalled products. Especial attention should then be paid to if any of these parties experienced an adverse event from using one of the sterile preparations.
Any additional adverse events should be reported to the FDA’s Medwatch Program and Franck’s Compounding Pharmacy directly.