Archive
846 recalls were announced in November 2018.
Of the 846 recalls this month scored against our rubric, 17% are Critical, 30% are Severe.
Which agencies issued them
Dexter Axle Company is recalling specific trailer axles because inner hub bearings may lack sufficient grease, risking overheating and failure.
Pharm D Solutions is recalling 881 vials of HCG Lyopholized 1200 IU Injectable nationwide due to a lack of assurance of sterility.
Pharm D Solutions is recalling 442 vials of HCG 6000 unit injectable nationwide due to a lack of assurance of sterility.
Pharm D Solutions is recalling Dexpanthenol Injection due to a lack of assurance of sterility. The product was distributed nationwide.
Pharm D Solutions is recalling Trimix BM3 Papaverine 30 mg/Phentolamine 1 mg Injectable because the agency could not ensure the product was sterile.
Pharm D Solutions is recalling 420 vials of Sermorelin/GHRP-2/GHRP-6 powder nationwide due to a lack of assurance of sterility.
Pharm D Solutions is recalling Prostaglandin E1 150 mcg/mL Injectable because the agency could not ensure the product was sterile.
Siemens is recalling 31 Ysio MAX radiographic systems because steel cables in the lifting column may rupture, causing the arm to drop unexpectedly.
Leica Microsystems is recalling BOND Slide Labeler Zebra Printers because the power supply unit may overheat or cause a fire due to an improperly-mixed phosphorus compound.
Pharm D Solutions is recalling Beta-complex B-1, B-6, B-3, B-12, B-5 100, 2.54 Injectable due to lack of assurance of sterility. The product was distributed nationwide.
Sprayology is recalling 919 bottles of Acne Tonic Homeopathic Oral Spray because manufacturing conditions could result in possible microbial contamination.
Zimmer Biomet is recalling 4,879 OsteoGen Implantable Bone Growth Stimulators because the company could not ensure product cleanliness parameters were consistently met.
Pharm D Solutions is recalling 1,171 vials of HCG 10,000 unit/0.3 gm Mannitol Lyopholized nationwide due to a lack of assurance of sterility.
Pharm D Solutions is recalling 124 vials of Sermorelin/GHRP-2 powder nationwide because the company cannot ensure the product is sterile.
Pharm D Solutions is recalling 10 bags of Sterile Water 50 mL Aqueous Solution because the company cannot guarantee the product's sterility.
Siemens is recalling 35 Multix Fusion radiographic systems because steel cables in the lifting column may rupture without triggering the safety lock, causing the arm to drop unexpectedly.
Pharm D Solutions is recalling specific lots of Methylcobalamin 1 mg/mL injectable because the company cannot ensure the product is sterile.
Pharm D Solutions is recalling specific lots of Prostaglandin E1 40 mcg/mL Injectable because the agency cannot assure the product is sterile.
Pharm D Solutions is recalling 29 vials of Bi-Mix (Papaverine/Phentolamine) injectable and powder nationwide due to a lack of assurance of sterility.
Pharm D Solutions is recalling 765 vials of HCG 3000 Unit Powder nationwide due to a lack of assurance of sterility.
Sprayology is recalling Body Skin Tonic homeopathic oral spray because it was manufactured under conditions that could result in possible microbial contamination.
Pharm D Solutions is recalling 12 bags of Water Sterile for Injection due to a lack of assurance of sterility. The product was distributed nationwide.
SLR Food Distribution, Inc. is recalling Sugar Melon Candy / Wax Gourd because the product contains undeclared sulfites. The recall covers 30 cases distributed to six states.
Pharm D Solutions is recalling 264 vials of Oxytocin 30 unit in LR 500 mL IV bags nationwide due to a lack of assurance of sterility.
Pharm D Solutions is recalling Trimix 30-1-30 aqueous solution because the company cannot assure the product's sterility.
Feel Good Foods Inc is recalling frozen Vegetable Fried Rice because it contains undeclared egg. The product was distributed in six states.
P. East Trading Corp. is recalling Fruits Du Sud Golden Seedless Raisins because the product contains undeclared sulfites.
Pharm D Solutions is recalling Phenol 7% and Glycerin Aqueous Solution 10 mL Injectable due to a lack of assurance of sterility.
Pharm D Solutions is recalling Prostaglandin E1 80 mcg/mL Injectable nationwide due to a lack of assurance of sterility.
Siemens is recalling 11 AXIOM Multix MT patient tables because steel cables may rupture, causing the arm to drop unexpectedly during patient positioning.
Siemens is recalling 142 Ysio radiographic systems because steel cables may rupture, causing the tube arm to drop unexpectedly during patient positioning.
Pharm D Solutions is recalling Bi-Mix Injection due to a lack of assurance of sterility. The product is distributed nationwide.
Apollo Food International Inc. is recalling Mini Rolls due to undeclared eggs. The product was distributed in Massachusetts, New York, and New Jersey.
Pharm D Solutions is recalling specific lots of Trimix T105 injectable solution because the company cannot ensure the product is sterile.
Pharm D Solutions is recalling specific lots of Calcium Gluconate 10% Injectable because the company cannot guarantee the product is sterile.
Pharm D Solutions is recalling Bi-Mix Injection (Alprostadil/Lidocaine) because the company cannot ensure the product is sterile. The recall covers nationwide distribution.
Pharm D Solutions is recalling 195 vials of Trimix injection nationwide due to a lack of assurance of sterility.
Pharm D Solutions is recalling 25 bottles of Calcium Gluconate 1% Eyewash Ophthalmic Solution because the company cannot ensure the product is sterile.
Maquet Datascope is recalling Cardiosave Rescue IABP devices due to a potential inability to start therapy at altitudes above 3,200 feet.
Pharm D Solutions is recalling 409 vials of Sermorelin/GHRP-2 powder because the company cannot ensure the product is sterile.
Stryker GmbH is recalling 1,355 Hoffman LRF Hexapod Struts because a manufacturing defect may cause the pin to displace, compromising frame stability.
Pharm D Solutions is recalling Glycerin 72% Injectable due to a lack of assurance of sterility. The product was distributed nationwide.
Stryker GmbH is recalling 578 Hoffmann LRF Hexapod Struts because a manufacturing defect may cause the pin to displace, compromising the stability of the orthopedic frame.
Pharm D Solutions is recalling HCG Reconstitued 6000 IU Injectable vials because the company cannot ensure the product is sterile.
Avella of Deer Valley is recalling 300 bags of Phenylephrine 30 mg in NS 250 mL due to a lack of assurance of sterility.
Pharm D Solutions is recalling 2,737 vials of HCG 4000 Unit Injectable nationwide due to a lack of assurance of sterility.
Pharm D Solutions is recalling HCG Reconstitued 50,000 IU Injectable because the product lacks assurance of sterility.
Kubota is recalling about 121,100 mowers and compact tractors because hot coolant can spray out, posing a burn hazard. Three burn injuries have been reported.
Pharm D Solutions is recalling 430 vials of Trimix injection because the company cannot guarantee the product is sterile.
Pharm D Solutions is recalling specific lots of Trimix ST-9B aqueous solution because the company cannot guarantee the product's sterility.
Pharm D Solutions is recalling Tilarginine Acetate 50 mg/mL injectable vials because the company cannot ensure the product is sterile.
Pharm D Solutions is recalling 70 bottles of Epi-Shugarcaine Kit Solution because the company cannot ensure the product is sterile.
Pharm D Solutions is recalling 114 vials of HCG 50,000 unit lyophilized powder nationwide due to a lack of assurance of sterility.
Pharm D Solutions is recalling Slenderella Compound Injectable because the product lacks assurance of sterility.
Sprayology is recalling Snore Soother Homeopathic Oral Spray because it was manufactured under conditions that could result in possible microbial contamination.
Maquet Datascope is recalling Cardiosave Hybrid IABP devices due to a potential inability to start therapy for users at altitudes above 3,200 feet.
Pharm D Solutions is recalling specific lots of Testosterone Cypionate/Proprinate 200 mg/10 mg/1 mL 30 mL Injectable because of a lack of assurance of sterility.
Pharm D Solutions is recalling specific lots of Phosphate Buffer Solution 0.05 m Aqueous Solution because the company cannot assure the product's sterility.
Avella of Deer Valley, Inc. is recalling 360 bags of Hydromorphone in NS due to a lack of assurance of sterility. The product was distributed nationwide.
Pharm D Solutions is recalling specific lots of Trimix T-106 aqueous solution because the company cannot ensure the product is sterile.
Pharm D Solutions is recalling Bi-Mix Injection due to a lack of assurance of sterility. The product was distributed nationwide.
Pharm D Solutions is recalling Phenol 5% and Glycerin Aqueous Solution 10 mL Injection due to a lack of assurance of sterility.
Pharm D Solutions is recalling 108 vials of Sermorelin/GHRP-2/Theanine/Mannitol powder because the company cannot ensure the product is sterile.
Pharm D Solutions is recalling 29 bottles of Calcium Gluconate 1% Eyewash because the company cannot ensure the product is sterile.
Pharm D Solutions is recalling Pyridoxine 100 mg/mL injectable vials due to a lack of assurance of sterility. The product was distributed nationwide.
Pharm D Solutions is recalling Acetylcysteine Injection 10 mg/5 mL because the agency could not ensure the product was sterile.
Pharm D Solutions is recalling specific lots of Magnesium 40 gm/ns 1000 mL IV solution because there is a lack of assurance of sterility.
D & D Foods is recalling Hy-Vee Spinach, Tomato, Mozzarella Twice Baked Potatoes because raw ingredients may be contaminated with Listeria monocytogenes and Salmonella.
Pharm D Solutions is recalling Testosterone in Grapeseed Oil Injectable because the product lacks assurance of sterility. The recall covers multiple vial sizes distributed nationwide.
Pharm D Solutions is recalling Sermorelin/GHRP-2 powder because the company cannot ensure the product is sterile.
Pharm D Solutions is recalling 521 syringes of Vigamox Ophthalmic Solution nationwide due to a lack of assurance of sterility.
Pharm D Solutions is recalling Arginine Injections 100 mcg/mL due to a lack of assurance of sterility. The affected lots were distributed nationwide.
Pharm D Solutions is recalling QM-4A Quadmix Atropine 0.4 mg Aqueous Solution because there is a lack of assurance of sterility.
Avella of Deer Valley is recalling 300 bags of Phenylephrine 25 mg in NS 250 mL due to a lack of assurance of sterility.
Pharm D Solutions is recalling specific lots of Trimix Injectable because the company cannot guarantee the product is sterile.
Pharm D Solutions is recalling 945 syringes of Epinephrine 1 mg/1 mL injectable solution nationwide due to a lack of assurance of sterility.
Pharm D Solutions is recalling Trimix T-101 injection because the product may lack assurance of sterility.
Pharm D Solutions is recalling specific lots of Trimix aqueous solution because the agency could not ensure the product was sterile.
Pharm D Solutions is recalling specific lots of a compounded medication solution because the company cannot guarantee the product is sterile.
Pharm D Solutions is recalling Caffeine and Sodium Benzoate Injection 125 mg/125 mg/mL due to a lack of assurance of sterility. The recall covers 567 milliliters distributed nationwide.
Pharm D Solutions is recalling specific lots of Trimix Injectable because the agency could not ensure the product was sterile.
Pharm D Solutions is recalling Ascorbic Acid 500 mg/mL Solution due to a lack of assurance of sterility. The recall affects nationwide distribution.
Eaton is recalling specific heavy-duty truck clutches because an internal component may fail, potentially causing unintended vehicle movement and increasing crash risk.
Pharm D Solutions is recalling 815 vials of Trimix injection because the company cannot guarantee the product is sterile.
Stryker GmbH is recalling 867 Hoffman LRF Hexapod Struts because a manufacturing defect may cause the pin to displace, compromising the stability of the medical device.
Stryker GmbH is recalling 832 Hoffman LRF Hexapod Struts because a manufacturing defect may cause the pin to displace, compromising the stability of the orthopedic frame.
Pharm D Solutions is recalling 330 vials of Sermorelin/GHRP-2 Powder because the company cannot ensure the product is sterile.
Avella of Deer Valley is recalling 1,360 bags of Morphine in NS due to a lack of assurance of sterility. The product was distributed nationwide.
Pharm D Solutions is recalling Trimix BM3 Papaverine 60 mg/Phentolamine 4 mg Injectable because the agency could not ensure the product was sterile.
Pharm D Solutions is recalling 50 mL bags of 0.9% Sodium Chloride for Injection because the company cannot ensure the product is sterile.
Pharm D Solutions is recalling specific lots of Trimix ST-1 aqueous solution because the company cannot ensure the product is sterile.
Sprayology is recalling 4,153 bottles of AllergEase Homeopathic Oral Spray because manufacturing conditions could result in possible microbial contamination.
Philips is recalling Ingenuity CT scanners with software version 4.1.6 because the Calcium Score report may display confusing information, potentially leading to patient mistreatment.
Pharm D Solutions is recalling 517 syringes of Reck Injection because the product lacks assurance of sterility. The recall covers lots distributed nationwide.
Inpeco S.A. is recalling 679 laboratory automation systems because some modules are missing safety pacemaker labels. The recall addresses a risk of pacemaker malfunction for personnel working near the equipment.
Sprayology is recalling Brain Power Homeopathic Oral Spray because it was manufactured under conditions that could result in possible microbial contamination.
Pharm D Solutions is recalling 2,219 vials of HCG Lyophilized 5000 IU Injectable because the product lacks assurance of sterility.
Becton Dickinson is recalling 23 BD Max Instrument Reader Spare Parts due to a confirmed trend of false positive Candida glabrata results.
Caito Foods LLC is recalling 244 units of Southwest Crimini Stuffed Mushrooms due to potential contamination with Listeria monocytogenes or Salmonella.
Philips is recalling Ingenuity Core 128 CT scanners with software version 4.1.6 because the Calcium Score report may display confusing information, potentially leading to patient mistreatment.
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