FDA (Drugs) recall action 62443
The FDA (Drugs) publishes a recall like this one as 98 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 98 pages.
Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Franck's Lab Inc. is recalling sterile Rubidium 200mcg/mL injectable products distributed between November 2011 and May 2012. The recall was initiated after FDA sampling found microorganisms and fungal growth in the clean room used for preparation.
Franck's Lab Inc. is recalling sterile levofloxacin injectable solutions because FDA sampling found microorganisms and fungal growth in the clean room where they were prepared.
Franck's Lab Inc. is recalling sterile human drugs, including Theracys, because FDA testing found microorganisms and fungal growth in the clean room where the products were prepared.
Franck's Lab Inc. is recalling sterile human drugs distributed between November 2011 and May 2012 because FDA sampling found microorganisms and fungal growth in the clean room.
Franck's Lab Inc. is recalling sterile injectable drugs distributed between November 2011 and May 2012 after FDA sampling found microorganisms and fungal growth in the clean room.
Franck's Lab Inc. is recalling specific povidone-iodine ophthalmic solutions because FDA testing found microorganisms in the production clean room.
Franck's Lab Inc. is recalling Isosulfan Blue 1% Injectable due to microorganisms and fungal growth found in the clean room where sterile products were prepared.
Franck's Lab Inc. is recalling sterile injectable drugs distributed between November 2011 and May 2012 after FDA sampling found microorganisms and fungal growth in the clean room.
Franck's Lab Inc. is recalling sterile phenylephrine injectable drugs distributed between November 2011 and May 2012 because FDA sampling found microorganisms and fungal growth in the clean room.
Franck's Lab Inc. is recalling sterile Vanadyl Sulfate Solution injectable because FDA sampling found microorganisms and fungal growth in the preparation clean room.
Franck's Lab Inc. is recalling sterile progesterone injections distributed between November 2011 and May 2012 because FDA testing found microorganisms and fungal growth in the production clean room.
Franck's Lab Inc. is recalling sterile insulin products distributed between November 2011 and May 2012 because FDA sampling found microorganisms and fungal growth in the clean room.
Franck's Lab Inc. is recalling sterile ketorolac tromethamine injectable products because environmental sampling found microorganisms and fungal growth in the clean room where they were prepared.
Franck's Lab Inc. is recalling sterile ophthalmic solutions because FDA testing found microorganisms and fungal growth in the clean room where they were prepared.
Franck's Lab Inc. is recalling sterile ophthalmic solutions distributed between November 2011 and May 2012 because FDA sampling found microorganisms and fungal growth in the clean room.
Franck's Lab Inc. is recalling Strontium 1 mg/mL Injectable due to microorganisms found in the clean room where sterile products were prepared.
Franck's Lab Inc. is recalling sterile molybdenum injectable products because FDA testing found microorganisms and fungal growth in the clean room where they were prepared.
Franck's Lab Inc. is recalling Prednisolone Acetate 10mg/ml Injectable because FDA testing found microorganisms in the production clean room.
Franck's Lab Inc. is recalling sterile Paclitaxel injectable products distributed between November 2011 and May 2012 because FDA sampling found microorganisms and fungal growth in the clean room.
Franck's Lab Inc. is recalling sterile ophthalmic drugs distributed between November 2011 and May 2012 because FDA sampling found microorganisms in the clean room.
Franck's Lab Inc. is recalling Lidocaine/Tetracaine Ophthalmic Solution because FDA testing found microorganisms and fungal growth in the clean room where the sterile drugs were prepared.
Franck's Lab Inc. is recalling sterile vancomycin and dexamethasone kits because FDA testing found microorganisms and fungal growth in the clean room where the drugs were prepared.
Franck's Lab Inc. is recalling sterile selenium injectable products because FDA testing found microorganisms and fungal growth in the clean room where they were prepared.
Franck's Lab Inc. is recalling sterile Papaverine HCL injectable vials because FDA sampling found microorganisms and fungal growth in the clean room where they were prepared.
Franck's Lab Inc. is recalling sterile ophthalmic trypan blue solutions because FDA sampling found microorganisms and fungal growth in the clean room where they were prepared.