FDA (Drugs) recall action 62416
The FDA (Drugs) publishes a recall like this one as 100 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 100 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 because 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 specific sterile ophthalmic drugs because FDA testing found microorganisms and fungal growth in the facility's clean room.
Franck's Lab Inc. is recalling sterile injectable drugs distributed between November 2011 and May 2012 because FDA testing found microorganisms in the production clean room.
Franck's Lab Inc. is recalling sterile Baclofen drugs because FDA sampling found microorganisms and fungal growth in the clean room where they were prepared.
Franck's Lab Inc. is recalling Acetazolamide injectable vials because FDA sampling found microorganisms in the clean room where they were prepared.
Franck's Lab Inc. is recalling Cisplatin 1mg/ml injectable products because FDA sampling found microorganisms in the clean room where they were prepared.
Franck's Lab Inc. is recalling sterile diazepam injectable drugs because FDA sampling found microorganisms and fungal growth in the clean room where they were prepared.
Franck's Lab Inc. is recalling specific sterile intrathecal drug mixtures because FDA testing found microorganisms in the production clean room.
Franck's Lab Inc. is recalling 19 units of sterile injectable drugs, including ascorbic acid and vitamin blends, because FDA sampling found microorganisms in the production clean room.
Franck's Lab Inc. is recalling 72 units of sterile estradiol products distributed between November 2011 and May 2012 because FDA sampling found microorganisms in the clean room.
Franck's Lab Inc. is recalling sterile Ganciclovir injectable syringes because FDA testing found microorganisms and fungal growth in the clean room where the drugs were prepared.
Franck's Lab Inc. is recalling sterile intrathecal Baclofen/Morphine mixtures distributed between November 2011 and May 2012 due to microbial contamination found in the clean room.
Franck's Lab Inc. is recalling sterile bupivacaine and fentanyl intrathecal solutions due to microbial contamination found in the clean room.
Franck's Lab Inc. is recalling sterile ethyl alcohol injections because FDA sampling found microorganisms and fungal growth in the production clean room.
Franck's Compounding Lab is recalling Indocyanine Green injectable kits because FDA sampling found microorganisms and fungal growth in the clean room where sterile products were prepared.
Franck's Lab Inc. is recalling sterile injectable drugs containing bupivacaine, lidocaine, and methylprednisolone because FDA sampling found microorganisms and fungal growth in the clean room.
Franck's Lab Inc. is recalling specific acetylcysteine ophthalmic solutions because FDA sampling found microorganisms and fungal growth in the clean room where they were prepared.
Franck's Lab Inc. is recalling specific sterile hydromorphone/clonidine intrathecal drugs due to microorganisms and fungal growth found in the clean room.
Franck's Lab Inc. is recalling specific sterile DMSO and Heparin solutions because FDA testing found microorganisms and fungal growth in the production clean room.
Franck's Lab Inc. is recalling sterile injectable drugs distributed between November 2011 and May 2012 because FDA sampling found microorganisms in the clean room.
Franck's Lab Inc. is recalling sterile hyaluronidase and lidocaine injectables because FDA sampling found microorganisms and fungal growth in the clean room where the products were prepared.
Franck's Lab Inc. is recalling sterile injectable drugs distributed between November 2011 and May 2012 because FDA sampling found microorganisms in the clean room.
Franck's Compounding Lab is recalling sterile Amphotericin B drugs distributed between November 2011 and May 2012 because FDA sampling found microorganisms in the clean room.
Franck's Lab Inc. is recalling sterile Doxorubicin HCL vials because FDA sampling found microorganisms and fungal growth in the clean room where the drugs were prepared.
Franck's Lab Inc. is recalling sterile ophthalmic drugs distributed between November 2011 and May 2012 because FDA sampling found microorganisms and fungal growth in the clean room.
Franck's Lab is recalling specific sterile eye drops because FDA testing found microorganisms and fungal growth in the production clean room.