Archive
576 recalls were announced in November 2021.
Of the 576 recalls this month scored against our rubric, 0% are Critical, 42% are Severe.
Which agencies issued them
Mack Trucks is recalling 2021 Granite and LR vehicles because a power steering pump defect may cause loss of assist, increasing crash risk.
Red Mountain Compounding Pharmacy is recalling MIT/B12 25/50/50MG/ML 1MG/ML multidose vials due to FDA inspection findings that raised concerns about the lack of assurance of sterility. The product was distributed to approximately 494 patients across seven states.
Red Mountain Compounding Pharmacy is recalling Calcium Chloride 100 mg/mL multi-dose vial injection due to lack of assurance of sterility identified during FDA inspection. The product was distributed to approximately 494 patients across seven states.
First Royal Care Compounding Pharmacy is recalling Test Cyp 50mg/ml in ethyl oleate oil due to FDA inspection findings that raised concerns about sterility assurance. About 494 patients in seven states received prescriptions for the affected product.
Red Mountain Compounding Pharmacy is recalling levocarnitine 100 mg/mL injectable solution (all lots within expiry) due to FDA inspection findings that raised sterility assurance concerns. Approximately 494 patients in seven states received prescriptions.
Red Mountain Compounding Pharmacy is recalling Progesterone 100mg/ml MDV Oil Injection due to lack of assurance of sterility following FDA inspection. About 494 patients in seven states received prescriptions for this affected product.
Red Mountain Compounding Pharmacy is recalling MIC/B12A 25/50/50MG/ML 1MG/ML MDV injectable medication because FDA inspection found the firm could not guarantee the sterility of the product. Approximately 494 patients across seven states received prescriptions for this medication.
Red Mountain Compounding Pharmacy is recalling Ascorbic Acid (Non-Corn) 500mg/mL multi-dose solution due to FDA inspection findings regarding lack of sterility assurance. The affected product was distributed to approximately 494 patients across seven states.
Red Mountain Compounding Pharmacy is recalling TEST CYP 200MG/ML MDV ETHYL OLEATE due to FDA inspection findings of lack of assurance of sterility. The product was distributed to approximately 494 patients across seven states.
Red Mountain Compounding Pharmacy is recalling folic acid injectable medication because the FDA found the product lacks adequate sterility assurance. The recall affects prescriptions distributed across multiple states.
Red Mountain Compounding Pharmacy is recalling Methylcobalamin 5000 mcg/mL multi-dose vial injection due to lack of assurance of sterility identified during FDA inspection. The product was distributed to approximately 494 patients in Arizona, California, Florida, Minnesota, Montana, Texas, and Utah.
First Royal Care Compounding Pharmacy is recalling Hydroxyprogesterone Caproate 250 mg/mL oil injection due to lack of assurance of sterility identified during FDA inspection. The drug was distributed to patients in seven states.
Red Mountain Compounding Pharmacy is recalling Acetylcysteine 10% ophthalmic solution due to lack of sterility assurance identified during an FDA inspection. Approximately 494 patients received prescriptions for the product across seven states.
Elekta's Oncentra Brachy versions 4.0+ may calculate incorrect doses for two-channel ovoid applicators in certain circumstances. Approximately 1,072 devices distributed worldwide.
Smiths Medical ASD Inc. is recalling 2,191 Bivona Uncuffed Wire Endotracheal Tubes due to inadequate pouch seals that compromise the sterile barrier. Affected devices have 325mm shaft lengths and were distributed nationwide and internationally.
Red Mountain Compounding Pharmacy is recalling Dexpanthenol 250mg/mL injection solution due to FDA findings that sterility assurance cannot be confirmed. The product was distributed to approximately 494 patients across seven states.
Xstrahl's Concerto software used in X-ray therapy systems may fail to update treatment parameters for a second beam when a treatment plan is edited. This could result in error messages and incorrect treatment delivery.
Rolls-Royce is recalling 2019-2022 Phantom vehicles because the central display may not raise correctly, partially blocking the rearview camera image.
Becton Dickinson & Company is recalling BD Syringe Tip Caps (Catalog Number 305822, Lot 1111347) due to holes in the packaging that may compromise sterility and container closure integrity.
Red Mountain Compounding Pharmacy is recalling TEST CYP 25MG/ML in Ethyl Oleate because FDA inspection raised concerns about sterility assurance. Approximately 494 patients in seven states received prescriptions for this drug.
Potomac River Group recalls 62 RAPTAR Laser Range Finders (Model G02) nationwide. The devices can be field-modified to enable higher-power visible and infrared lasers, posing eye injury risk from uncontrolled laser radiation.
Medtronic is recalling 591 units of C315-HIS Delivery Catheters due to reports that a lead cannot pass through the catheter. The catheters were distributed internationally to multiple countries, and healthcare providers should contact Medtronic for guidance.
W L Gore recalled 846 GORE CARDIOFORM Septal Occluder units labeled with a 3-year expiration instead of the correct 2-year expiration.
Siemens is recalling Advia Chemistry Urinary/Cerebrospinal Fluid Protein reagent due to potential reagent carryover that may cause falsely depressed Hemoglobin A1c results, which could affect clinical decisions about patient treatment.
W.L. Gore is recalling 138 units of GORE Cardioform Septal Occluder devices labeled with a 3-year expiration date instead of the actual 2-year shelf life.
W L Gore & Associates is recalling 222 GORE Cardioform Septal Occluder devices labeled with a 3-year expiration date instead of the correct 2-year expiration.
Usines Giant Factories is recalling about 168 gas water heaters with Emerson control valves that can short circuit, overheat, and release carbon monoxide. The company will replace the control valve free of charge.
First Royal Care Co. LLC, operating as Red Mountain Compounding Pharmacy, is recalling Testosterone Ultra 250MG/ML in sesame oil due to lack of assurance of sterility identified during FDA inspection.
Volkswagen is recalling one 2021 ID.4 vehicle with a defective steering gear. A missing or incorrectly assembled drive bushing may cause loss of steering control and increase crash risk.
Smiths Medical is recalling 7136 Bivona Aire-Cuf Endotracheal Tubes due to inadequate pouch seals that compromise the sterile barrier. The issue affects specific lot numbers with 325mm shaft length.
W.L. Gore & Associates is recalling 2,238 GORE CARDIOFORM SEPTAL OCCLUDER 30 mm devices labeled with a 3-year expiration date instead of the actual 2-year expiration date.
Red Mountain Compounding Pharmacy is recalling Acetylcysteine 2% Ophthalmic Solution due to lack of assurance of sterility. The FDA identified concerns during an inspection of the manufacturing facility.
Red Mountain Compounding Pharmacy is recalling pyridoxine HCL (vitamin B6) injectable solution due to lack of assured sterility. Approximately 494 patients in multiple states received affected prescriptions.
Volkswagen is recalling 2022 Tiguan vehicles with a loose brake pipe nut near the right-front wheel well. The loose nut could cause brake fluid to leak, reducing braking power and increasing crash risk.
Simple Mills has recalled Almond Flour Crackers with fine ground sea salt because they contain undeclared milk allergen. The product was distributed across 36 states.
Red Mountain Compounding Pharmacy is recalling testosterone cypionate 200mg/ml in sesame oil due to FDA concerns about lack of sterility assurance. The product was distributed to approximately 494 patients across seven states.
Red Mountain Compounding Pharmacy is recalling Vitamin B Complex Injectable Solution (HP) due to lack of assurance of sterility raised during FDA inspection. Approximately 494 patients across seven states received affected prescriptions.
Red Mountain Compounding Pharmacy is recalling Benzalkonium Chloride 0.013% Solution due to lack of assurance of sterility identified during an FDA inspection. Approximately 494 patients in seven states received prescriptions for this product.
Red Mountain Compounding Pharmacy is recalling a testosterone-blend injection product due to FDA concerns about sterility assurance. The product was distributed to patients in seven states.
Red Mountain Compounding Pharmacy is recalling Calcium Gluconate 10% Injectable (PF) due to lack of assurance of sterility following an FDA inspection. The product was distributed to approximately 494 patients across seven states.
Red Mountain Compounding Pharmacy is recalling MIC 25/50/50MG/ML MDV injectable medication due to lack of assurance of sterility following an FDA inspection. Approximately 494 patients in seven states received prescriptions for the affected product.
Red Mountain Compounding Pharmacy is recalling Vitamin B Complex Injection Solution because FDA inspection raised concerns about sterility assurance. Approximately 494 patients in seven states received the affected product.
Olympus recalls ASC PneumoLiner surgical devices due to incorrect orientation of the containment bag that deploys upside down. This increases the risk of trapping bowel tissue during gynecologic laparoscopic surgery.
W L Gore & Associates is recalling 187 units of GORE CARDIOFORM Septal Occluders because they are labeled with a 3-year expiration date instead of the correct 2-year expiration date. Using the device beyond its actual shelf life could compromise its safety and effectiveness.
AB SCIEX's Cliquid MD version 3.4 software may incorrectly calculate Internal Standard concentrations when users hide or leave the IS column empty in customized LC-MS/MS tests, potentially leading to incorrect analytical conclusions.
Siemens Healthcare is recalling Atellica CH Urinary/Cerebrospinal Fluid Protein reagent due to potential carryover causing falsely depressed Hemoglobin A1c results that may affect clinical decision-making.
Red Mountain Compounding Pharmacy is recalling Cyclosporin 0.2% Oil Ophthalmic Suspension because FDA inspection identified concerns about sterility assurance. The recalled drug was distributed to approximately 494 patients across multiple states.
Red Mountain Compounding Pharmacy is recalling Magnesium Chloride 200 mg/mL injection because FDA inspection raised concerns about lack of assurance of sterility. The product was distributed to approximately 494 patients in seven states.
Macleods Pharma USA is recalling Rizatriptan Benzoate 5mg orally disintegrating tablets nationwide due to out-of-specification results in organic impurities testing. The affected lots are BRL2102A and BRL2103A with expiration date 04/2025.
Occidental Chemical Corporation is recalling food grade anhydrous calcium chloride pellets due to potential contamination with fragments of blue high-density polyethylene (HDPE). The recall affects 11,275 bags distributed to food processors and related industries.
MacLeods Pharma USA is recalling Rizatriptan Benzoate Film Coated Tablets (10 mg) due to out-of-specification test results in organic impurities testing. The recall affects multiple lot numbers distributed nationwide.
Ultra Seal Corporation is recalling Advance Formula Pain Reliever tablets (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) distributed nationwide due to out-of-specification results for Salicylic Acid, an Aspirin-related compound.
Ultra Seal Corporation is recalling PainAway II tablets nationwide due to failed stability specifications. Testing found out-of-specification levels of Salicylic Acid, an aspirin-related compound.
Ultra Seal Corporation is recalling Xpect First Aid Extra Strength Pain Away tablets nationwide due to out-of-specification results for Salicylic Acid, a compound related to Aspirin, indicating failed stability testing.
Red Mountain Compounding Pharmacy is recalling a methylcobalamin injectable solution after FDA inspection raised concerns about the lack of assurance of sterility.
Red Mountain Compounding Pharmacy is recalling Sodium Selenite 200mcg/ml injectable solution due to FDA inspection findings regarding lack of assurance of sterility. Approximately 494 patients in seven states received prescriptions for this product.
Lupin Pharmaceuticals is recalling Gatifloxacin Ophthalmic Solution 0.5% due to failed water loss tests that may affect drug concentration. The recall affects 16,272 bottles distributed nationwide.
W L Gore & Associates is recalling GORE CARDIOFORM Septal Occluder devices labeled with a 3-year expiration date instead of the correct 2-year date. Mislabeling could result in use of devices beyond their intended safe lifespan.
W L Gore & Associates recalls GORE CARDIOFORM SEPTAL OCCLUDER devices labeled with a 3-year expiration date when the actual shelf life is 2 years. The mislabeling affects 15 units distributed across the United States and internationally.
GORE CARDIOFORM SEPTAL OCCLUDER devices are recalled for labeling errors: 95 units marked with 3-year expiration instead of correct 2-year date. Affected units distributed across US and international locations.
Sun Pharmaceutical Industries is recalling 22,752 blister packs of Loratadine-D Extended-Release Tablets (10mg/240mg) distributed nationwide due to failed moisture limits. The affected lot is AC14635 with expiration date 12/2022.
Ultra Seal Corporation is recalling Afassco Pain Free Plus X-Strength Pain Reliever tablets nationwide due to out-of-specification results for Salicylic Acid, a related compound of Aspirin, indicating failed stability testing.
W. L. Gore & Associates is recalling GORE CARDIOFORM Septal Occluders labeled with incorrect 3-year expiration dates instead of 2-year dates. This labeling error affects devices distributed across the United States and internationally.
Ultra Seal Corporation is recalling North by Honeywell Pain Stopper Extra Strength tablets nationwide because stability testing found out-of-specification results for Salicylic Acid, an aspirin-related compound.
Ultra Seal Corporation is recalling AERO Tab Pain Reliever tablets nationwide because out-of-specification results were found for Salicylic Acid, an Aspirin-related compound, indicating failed stability testing.
Elektron Power Handle BP-1 units can short circuit and overheat, creating fire and burn risks. Consumers should stop using them immediately and contact Elektron for a full refund.
Red Mountain Compounding Pharmacy is recalling MIC/B12A/B6 injectable medication because FDA inspection identified concerns about sterility assurance. The recall affects 494 patients across seven states.
Smiths Medical recalled two Pneupac paraPac plus 300 ventilator kits distributed in the UK that were labeled with the same serial number, preventing differentiation between the two units.
Macleods Pharma USA is recalling Rizatriptan Benzoate 10mg orally disintegrating tablets nationwide due to out-of-specification results in organic impurities testing of controlled samples.
SUN PHARMACEUTICAL INDUSTRIES INC is recalling Kirkland Signature AllerClear D 24 HR (Loratadine and Pseudoephedrine Sulfate) tablets nationwide because the product failed to meet moisture content limits.
Ultra Seal Corporation is recalling Vica-Cet Back Pain Relief tablets nationwide because certain lots failed stability testing and contain out-of-specification levels of Salicylic Acid, an aspirin-related compound.
Ultra Seal Corporation is recalling ZEE+ Painaid ESF Extra-Strength Formula tablets nationwide due to out-of-specification results for Salicylic Acid, an aspirin-related compound. The recall affects 50-count and 125-count packages with lot numbers AK-9547 (exp. April 22) and AK-9941 (exp. December 22).
Daimler Trucks is recalling 1,434 Thomas Built school buses because a loose alternator cable connection may cause electrical arcing and increase the risk of a fire.
FCA US is recalling 2020 Alfa Romeo Giulia vehicles because some may have tires with a lower load rating than intended, increasing crash risk.
Oshkosh is recalling 2020-2021 S-Series vehicles because a machining defect may cause the power steering pump shaft seal to break, resulting in a loss of steering assist.
Heartland Recreational Vehicles is recalling 2019-2021 Road Warrior and 2020-2021 Cyclone trailers because wire securement lugs may be improperly tightened. Loose wires can cause electrical arcing and increase fire risk.
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