Archive
846 recalls were announced in November 2018.
Of the 846 recalls this month scored against our rubric, 17% are Critical, 33% are Severe.
Which agencies issued them
Pharm D Solutions is recalling 881 vials of HCG Lyopholized 1200 IU Injectable nationwide due to a lack of assurance of sterility.
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 Ascorbic Acid 500 mg/mL Solution due to a lack of assurance of sterility. The recall affects nationwide distribution.
Pharm D Solutions is recalling 765 vials of HCG 3000 Unit Powder nationwide due to a lack of assurance of sterility.
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 Prostaglandin E1 150 mcg/mL Injectable because the agency could not ensure the product was sterile.
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 specific lots of a compounded medication solution because the company cannot guarantee the product is 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.
Avella of Deer Valley is recalling 20 syringes of Fentanyl (10 mcg/mL) in NS 1 mL due to a lack of assurance of sterility.
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-1 aqueous solution because the company cannot ensure the product is sterile.
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.
Aurobindo Pharma is recalling Irbesartan bulk active ingredient because N-Nitrosodimethylamine (NDEA), a carcinogen, was detected. The product was distributed to one customer in New York.
P. East Trading Corp. is recalling Fruits Du Sud Golden Seedless Raisins because the product contains undeclared sulfites.
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 Trimix T 101 Injectable due to a lack of assurance of sterility. The recall covers a specific lot distributed nationwide.
Pharm D Solutions is recalling 25 bottles of Calcium Gluconate 1% Eyewash Ophthalmic Solution because the company cannot ensure the product is sterile.
Pharm 184 vials of Zinc Sulfate 1 mg/mL MDV Injectable are being recalled nationwide due to a lack of assurance of sterility.
Pharm D Solutions is recalling Lipo MIC-12 Compound Injectable vials nationwide due to a lack of assurance of sterility.
Pharm D Solutions is recalling specific lots of Trimix QM10 Injectable 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 Prostaglandin E1 80 mcg/mL Injectable nationwide due to 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.
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 1,171 vials of HCG 10,000 unit/0.3 gm Mannitol Lyopholized nationwide due to a lack of assurance of sterility.
Zimmer Biomet is recalling SpF PLUS-Mini implantable spinal fusion stimulators because the company lacked adequate validation to ensure product cleanliness parameters were consistently met.
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 Slenderella Compound Injectable because the product lacks assurance of sterility.
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 1,355 Hoffman LRF Hexapod Struts because a manufacturing defect may cause the pin to displace, compromising frame stability.
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 Acetylcysteine Injection 10 mg/5 mL 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.
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 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 specific lots of Trimix Injectable because the company cannot guarantee the product is sterile.
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 409 vials of Sermorelin/GHRP-2 powder because the company cannot ensure the product is sterile.
Pharm D Solutions is recalling HCG Reconstitued 6000 IU Injectable vials because the company cannot ensure the product is sterile.
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 Trimix BM3 Papaverine 60 mg/Phentolamine 4 mg Injectable because the agency could not ensure the product was 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 specific lots of Calcium Gluconate 10% Injectable because the company cannot guarantee 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 609 vials of Tri-Mix Injectable due to a lack of assurance of sterility. The product was distributed nationwide.
Siemens is recalling 11 AXIOM Multix MT patient tables because steel cables may rupture, causing the arm to drop unexpectedly during patient positioning.
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 4,000 mL of Glutathione 200 mg/mL Solution because the product lacks assurance of sterility.
Pharm D Solutions is recalling Glutamine 10 mg/mL Solution because the product lacks assurance of sterility. The recall covers specific lots distributed nationwide.
Pharm D Solutions is recalling 815 vials of Trimix injection because the company cannot guarantee the product is sterile.
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 Methylcobalamin 1 mg/mL injectable because the company cannot ensure the product is sterile.
Pharm D Solutions is recalling QM-4A Quadmix Atropine 0.4 mg Aqueous Solution because there is a lack of assurance of sterility.
Pharm D Solutions is recalling 330 vials of Sermorelin/GHRP-2 Powder because the company cannot ensure the product is sterile.
Sprayology is recalling Body Skin Tonic homeopathic oral spray because it was manufactured under conditions that could result in possible microbial contamination.
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 124 vials of Sermorelin/GHRP-2 powder nationwide because the company cannot ensure the product is sterile.
Feel Good Foods Inc is recalling frozen Vegetable Fried Rice because it contains undeclared egg. The product was distributed in six states.
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 70 bottles of Epi-Shugarcaine Kit Solution because the company cannot ensure the product is sterile.
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 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 Testosterone in Grapeseed Oil Injectable because the product lacks assurance of sterility. The recall covers multiple vial sizes distributed nationwide.
Sprayology is recalling Snore Soother Homeopathic Oral Spray because it was manufactured under conditions that could result in possible microbial contamination.
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 50 mL bags of 0.9% Sodium Chloride for Injection because the company cannot ensure the product is sterile.
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 Pyridoxine 100 mg/mL injectable vials due to a lack of assurance of sterility. The product was distributed nationwide.
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 2,737 vials of HCG 4000 Unit Injectable nationwide due to a lack of assurance of sterility.
Sprayology is recalling 919 bottles of Acne Tonic Homeopathic Oral Spray because manufacturing conditions could result in possible microbial contamination.
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 Sermorelin/GHRP-2 powder because the company cannot ensure the product is sterile.
Pharm D Solutions is recalling Glycerin 72% Injectable 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 specific lots of Trimix T105 injectable solution because the company cannot ensure the product is sterile.
Pharm D Solutions is recalling HCG Reconstitued 50,000 IU Injectable because the product lacks assurance of sterility.
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.
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 10 bags of Sterile Water 50 mL Aqueous Solution because the company cannot guarantee the product's sterility.
Pharm D Solutions is recalling 285 vials of Bacteriostatic Water for Injection because the product lacks assurance of sterility.
Pharm D Solutions is recalling Trimix T-101 injection because the product may lack assurance of sterility.
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.
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 Tilarginine Acetate 50 mg/mL injectable vials 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 is distributed nationwide.
Pharm D Solutions is recalling 195 vials of Trimix injection nationwide due to a lack of 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 Trimix 30-1-30 aqueous solution because the company cannot assure the product's 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 specific lots of Trimix ST-9B aqueous solution because the company cannot guarantee the product's sterility.
Pharm D Solutions is recalling 517 syringes of Reck Injection because the product lacks assurance of sterility. The recall covers lots distributed nationwide.
Bakkavor Foods USA is recalling Trader Joe's Tomato & Basil Hummus Dip due to potential Salmonella and Listeria monocytogenes contamination.
Baxter Healthcare is recalling 281,350 units of EXACTAMIX Empty EVA Bags because they may leak after being used for compounding.
Roche Diagnostics is recalling 14,398 URISYS 1100 Urine Analyzers because limits of detection for certain parameters were higher than listed, potentially causing false negative results.
Sprayology is recalling 1,473 bottles of Life Detoxer Homeopathic Oral Spray because manufacturing conditions could result in possible microbial contamination.
World Variety Produce is recalling Melissa's Hatch Chile Clean Snax because peanuts are listed in ingredients but not in the allergen information.
Kidde is recalling specific fire extinguishers used in bus fire suppression systems because the actuator may fail to discharge the agent, increasing injury risk during a fire.
Sprayology is recalling Man Power Homeopathic Oral Spray because it was manufactured under conditions that could result in possible microbial contamination.
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