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 tetracaine ophthalmic solutions because FDA testing found microorganisms and fungal growth in the clean room where the drugs were prepared.
Franck's Lab Inc. is recalling sterile Verapamil HCL 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 Lorazepam 2mg/mL injectable products because FDA testing found microorganisms and fungal growth in the facility's clean room.
Franck's Lab Inc. is recalling Penicillin G Potassium Injectable due to microorganisms and fungal growth found in the clean room where sterile products were prepared.
Franck's Lab Inc. is recalling sterile Tetracosactide Acetate injectables 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 19 units of Iohexol injectable sterile 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 water products 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 L-Tryptophan 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 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 specific Pilocarpine HCL ophthalmic products because FDA testing found microorganisms and fungal growth in the facility's 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 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 Zinc Chloride 10mg/ml Injectable because FDA sampling found microorganisms and fungal growth in the clean room where sterile products were prepared.
Franck's Lab Inc. is recalling sterile lidocaine products distributed between November 2011 and May 2012 after FDA sampling found microorganisms and fungal growth in the clean room.
Franck's Compounding Lab 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 human drugs distributed between November 2011 and May 2012 because FDA testing found microorganisms and fungal growth in the clean room where they 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 Procaine HCL injectable products because FDA testing found microorganisms in the production clean room.
Franck's Lab Inc. is recalling sterile papaverine and alprostadil injectables distributed between November 2011 and May 2012 due to microbial contamination found in the clean room.
Franck's Lab Inc. is recalling sterile human 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 ophthalmic trypan blue solutions because FDA sampling found microorganisms and fungal growth in the clean room where they were prepared.
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 specific riboflavin ophthalmic solutions because FDA testing found microorganisms in the production clean room.
Franck's Lab Inc. is recalling Levothyroxine Sodium Injectable due to microorganisms and fungal growth found in the clean room where sterile products were prepared.
Franck's Lab Inc. is recalling Taurine 50mg/mL Injectable due to microorganisms and fungal growth found in the clean room where sterile products were prepared.