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 sterile ophthalmic drugs due to microbial contamination found in the clean room.
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 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 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 Acetazolamide injectable vials because FDA sampling found microorganisms in the clean room where they were prepared.
Franck's Lab Inc. is recalling sterile DMPS 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 sampling found microorganisms in the production clean room.
Franck's Compounding Lab is recalling sterile Amikacin drugs because FDA testing found microorganisms and fungal growth in the clean room where they were prepared.
Franck's Lab Inc. is recalling Depo-Testosterone injectable units because FDA sampling found microorganisms and fungal growth in the clean room where the sterile drugs 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 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 containing bupivacaine, lidocaine, and methylprednisolone because FDA sampling found microorganisms and fungal growth in the clean room.
Franck's Lab Inc. is recalling four sterile hydromorphone products because FDA sampling found microorganisms and fungal growth in the clean room where they were prepared.
Franck's Lab Inc. is recalling sterile glutathione products distributed between November 2011 and May 2012 because FDA testing found microorganisms and fungal growth in the clean room.
Franck's Lab Inc. is recalling sterile chromium picolinate injectable products because FDA sampling found microorganisms and fungal growth in the clean room where they were prepared.
Franck's Lab Inc. is recalling sterile bupivacaine/sufentanil injections because FDA sampling found microorganisms and fungal growth in the production clean room.
Franck's Lab Inc. is recalling sterile Aflibercept syringes 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 because FDA sampling found microorganisms in the clean room.
Franck's Lab Inc. is recalling sterile G-C-P 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 injectable drugs distributed between November 2011 and May 2012 because FDA testing found microorganisms and fungal growth 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 Lab Inc. is recalling sterile DMSO/Heparin/Methylprednisolone solution because FDA sampling found microorganisms and fungal growth in the clean room where the products were prepared.
Franck's Lab Inc. is recalling two units of Budesonide nasal irrigation solution because FDA testing found microorganisms 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 injectable drugs and ophthalmic products distributed between November 2011 and May 2012 because FDA testing found microorganisms in the production clean room.