Archive
875 recalls were announced in August 2012.
Of the 875 recalls this month scored against our rubric, 17% are Critical, 43% are Severe.
Which agencies issued them
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 Compounding Lab is recalling 92 units of morphine sulfate injectable products due to a lack of assurance of sterility.
Franck's Lab Inc. is recalling sterile diphenhydramine 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 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 Hydroxocobalamin injections because FDA testing found microorganisms and fungal growth in the production 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 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 Aflibercept syringes distributed between November 2011 and May 2012 because FDA sampling found microorganisms and fungal growth in the clean room.
Synthes USA HQ, Inc. is recalling 8,853 packs of Hemostatic Bone Putty because the product may ignite if contacted with electrosurgical cautery systems during surgery.
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 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 injectable drugs containing methylprednisolone and lidocaine because environmental sampling found microorganisms and fungal growth in the clean room.
Franck's Lab Inc. is recalling sterile Mitomycin 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 Cefazolin 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 distributed between November 2011 and May 2012 because FDA testing found microorganisms and fungal growth in the preparation clean room.
Franck's Lab Inc. is recalling sterile Fluorescein/Indocyanine 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 metoclopramide HCL injectable products because FDA sampling found microorganisms and fungal growth in the clean room where they were prepared.
Franck's Compounding Lab is recalling sterile leucovorin vials because FDA environmental sampling found microorganisms and fungal growth in the clean room where the products were prepared.
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 23 sterile injectable vitamin products because FDA sampling found microorganisms and fungal growth in the clean room where they were prepared.
Franck's Lab Inc. is recalling Forskolin/Phentolamine 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 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 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 ophthalmic 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 Taurine 50mg/mL Injectable due to microorganisms and fungal growth found in the clean room where sterile products were prepared.
Franck's Lab Inc. is recalling sterile tobramycin 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 because FDA sampling found microorganisms in the clean room.
Franck's Lab Inc. is recalling heparin sodium injectables because FDA sampling found microorganisms and fungal growth in the clean room where sterile products were prepared.
Franck's Lab Inc. is recalling specific sterile injectable drugs because FDA sampling found microorganisms and fungal growth in the production clean room.
Franck's Lab Inc. is recalling sterile injectable drugs, including nandrolone decanoate, after FDA sampling found microorganisms and fungal growth in the clean room.
Franck's Lab Inc. is recalling 48 units of Hydroxyprogesterone Caproate Injectable because FDA sampling found microorganisms and fungal growth in the clean room where the sterile drugs were prepared.
Franck's Lab Inc. is recalling Etomidate 0.2% Injectable because FDA sampling found microorganisms and fungal growth in the clean room where sterile products were prepared.
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 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 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 Procaine HCL injectable products because FDA testing found microorganisms in the production clean room.
Franck's Lab Inc. is recalling sterile voriconazole ophthalmic 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 hyaluronidase/methylprednisolone acetate injectable drugs because FDA sampling found microorganisms and fungal growth in the clean room.
Franck's Lab Inc. is recalling sterile Thiotepa 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 Folic Acid 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 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 Thiamine HCL injectable products because FDA sampling found microorganisms and fungal growth in the preparation clean room.
Philips Healthcare Inc. is recalling 12 Easy Diagnost Classic stationary x-ray systems because an incorrectly mounted inclination switch may fail to stop table tilting.
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 Compounding Lab is recalling 110 units of QUADMIX injectable drugs because FDA testing found microorganisms and fungal growth in the facility's clean room.
Franck's Lab Inc. is recalling specific sterile intrathecal drug mixtures because FDA sampling found microorganisms in the production 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 Acyclovir Ophthalmic 3% Ointment and 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 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 cyanocobalamin (Vitamin B12) 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 ophthalmic solutions distributed between November 2011 and May 2012 because FDA sampling found microorganisms and fungal growth in the clean room.
Fisker is recalling 1,377 model year 2012 Karma vehicles because a manufacturing defect in the low temperature cooling fan may cause a direct short and vehicle fire.
Franck's Lab Inc. is recalling four sterile intrathecal drug mixtures because FDA sampling found microorganisms and fungal growth in the clean room where they were prepared.
Franck's Lab Inc. is recalling four sterile injectable drug products because FDA sampling found microorganisms and fungal growth in the clean room where they were prepared.
Franck's Lab Inc. is recalling Labetalol Hydrochloride 5mg/mL injectable products due to microorganisms and fungal growth found in the clean room.
Franck's Lab Inc. is recalling six sterile intrathecal drug mixtures due to microbial contamination found 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 sterile midazolam 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 sterile clindamycin eye and injectable products due to microorganisms and fungal growth found in the clean room.
Franck's Lab Inc. is recalling 19 units of Ranibizumab injectable because FDA testing found microorganisms in the clean room where the sterile drugs were prepared.
CareFusion 303, Inc. is recalling Alaris Pump Module model 8100 units due to reports of motor stalls during infusion.
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 Lab Inc. is recalling Phentolamine 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 Ceftazidime ophthalmic products distributed between November 2011 and May 2012 because FDA sampling found microorganisms in the clean room.
Franck's Lab Inc. is recalling sterile 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 L-Arginine 500mg/mL injectable 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 four glycerin ophthalmic products because FDA testing found microorganisms and fungal growth in the facility's clean room.
Icrest International LLC is recalling frozen oyster meat from Korea because it was prepared under insanitary conditions that may have rendered it injurious to health.
Franck's Lab Inc. is recalling sterile Mannitol injectable drugs because FDA testing found microorganisms and fungal growth in the manufacturing clean room.
Franck's Lab Inc. is recalling sterile injectable drugs distributed between November 2011 and May 2012 because FDA sampling found microorganisms and fungal growth in the clean room.
Edwards Lifesciences is recalling Swan-Ganz Thermodilution VIP Catheters because a J-tip guidewire may pass through the distal lumen hub.
Baroody Imports Inc. is voluntarily recalling Chiclets Chewing Gum (Fruit Flavors) due to misbranded and unsafe color additives.
GE Healthcare is recalling Advantage Workstations with Advanced Vessel Analysis due to incorrect aorta measurements and potential issues with PET data loading.
Icrest International LLC is recalling Yatta brand oysters due to preparation under insanitary conditions that may have caused contamination.
Icrest International LLC is recalling frozen oyster meat from Korea because it was prepared under insanitary conditions, potentially rendering it injurious to health.
Edwards Lifesciences is recalling 32,145 units of Swan-Ganz Thermodilution VIP Catheters because a J-tip guidewire may pass through the distal lumen hub.
Edwards Lifesciences is recalling 32,145 Swan-Ganz Thermodilution VIP Catheters because a J-tip guidewire may pass through the distal lumen hub.
Southern Home is recalling specific lots of Pasta Salad Ranch with Bacon because they may contain metal fragments.
Zimmer, Inc. is recalling Trabecular Metal Reverse Shoulder Liner Impactors due to reports of alignment peg fractures in units made of 455 stainless steel.
Zimmer, Inc. is recalling specific Trabecular Metal Reverse Shoulder Liner Impactors due to reports of alignment peg fractures.
Zimmer, Inc. is recalling Trabecular Metal Reverse Shoulder Liner Impactors due to reports of alignment peg fractures in instruments made of 455 stainless steel.
Edwards Lifesciences is recalling Swan-Ganz Thermodilution VIP Catheters because a J-tip guidewire may pass through the distal lumen hub.
Edwards Lifesciences is recalling Swan-Ganz Thermodilution VIP Catheters because a J-tip guidewire may pass through the distal lumen hub.
Edwards Lifesciences is recalling Swan-Ganz Thermodilution VIP Catheters because a J-tip guidewire may pass through the distal lumen hub.
Edwards Lifesciences is recalling 32,145 Swan-Ganz Thermodilution VIP Catheters because a J-tip guidewire may pass through the distal lumen hub.
Carestream Health is recalling DRX-1 system batteries manufactured before June 2012 due to two reported instances of lithium-ion battery overheating that may cause burns.
Edwards Lifesciences is recalling Swan-Ganz Thermodilution VIP Catheters because a J-tip guidewire may pass through the distal lumen hub.
FunFresh Foods Inc is recalling 500 units of World Berry Organic Cacao Nibs 6 oz due to E. coli contamination. The product was distributed to health and natural food stores in 30 states.
Zimmer, Inc. is recalling specific Trabecular Metal Reverse Shoulder Liner Impactors due to reports of alignment peg fractures. The recall affects units manufactured from 455 stainless steel.
Energizer is recalling rotating night lights sold at Target because they can overheat and smoke, posing a burn hazard. No injuries have been reported.
Kawasaki is recalling about 7,000 Teryx4 recreational off-highway vehicles because the steering gear assembly and front brakes can fail, posing a risk of injury or death.
Icrest International LLC is recalling Oyster Meat IQF Large 5/4 Lbs due to preparation under insanitary conditions that may have contaminated the product.
Maquet Inc. is recalling certain pediatric arterial cannulas because the hardened tip may be too long, limiting flexibility during extracorporeal circulation procedures.
Edwards Lifesciences is recalling 32,145 units of Swan-Ganz Thermodilution VIP Catheters because a J-tip guidewire may pass through the distal lumen hub.
Edwards Lifesciences is recalling 32,145 units of Swan-Ganz Thermodilution VIP Catheters because a J-tip guidewire may pass through the distal lumen hub.
Edwards Lifesciences is recalling 32,145 Swan-Ganz Thermodilution VIP Catheters because a J-tip guidewire may pass through the distal lumen hub.
Nico Corp. is recalling 20 BrainPath sheaths because 50mm units were mislabeled as 60mm, creating a risk of improper fit during use.
AGFA Corp. is recalling IMPAX Cardiovascular Reporting software because user-entered conclusions were not printed on final reports.
DePuy Orthopaedics is retrieving 8,338 custom implant devices that were ordered but not implanted, following an FDA Warning Letter.
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