💊 Drugs Class I - Dangerous
Subpotent Drug
All Recalls
95,114 total recalls in our database
💊 Drugs Class I - Dangerous
Failed Stability Specifications
Tacrolimus Capsules, USP 5mg, 100-count bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505, NDC 0378-2047-01
Mylan Pharmaceuticals
💊 Drugs Class I - Dangerous
Presence of foreign tablet/capsule - Potential presence of commingled one Tacrolimus 1 mg capsule in 5 mg bottles.
💊 Drugs Class I - Dangerous
Subpotent Drug
Ibuprofen 200 mg liquid filled capsules Advil Liqui-Gel Minis, 160 count bottle NDC 0573-1769-89 NDC 0573-1769-95
Glaxosmithkline Consumer Healthcare Holdings
💊 Drugs Class I - Dangerous
Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel.
Ibuprofen 200 mg Chlorpheniramine Maleate 4mg Phenylephrine 10 mg tablets. Advil Allergy & Congestion Relief 10 and 20 count blister tray in carton NDC 0573-0196-10, item # F00573019610C, 10 ct. blister NDC 0573-0196-20, item # F00573019620C, 20 ct. blister NDC 0573-0196-10, item # F00573019610R, 10 ct. blister
Glaxosmithkline Consumer Healthcare Holdings
💊 Drugs Class I - Dangerous
Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel.
Advil Sinus Congestion and Pain/Advil Allergy and Congestion Relief 8 pc with $1 IRC (mixed product display - only Advil Allergy & Congestion is impacted). NDC # 0573-2161-14 SKU# F00573216114A (original lot # R73995) Co-packaged Batch/Lot # 0045DB, 9327VB, 0017DA & 9353WA
Glaxosmithkline Consumer Healthcare Holdings
💊 Drugs Class I - Dangerous
Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel.
💊 Drugs Class I - Dangerous
Subpotent Drug
💊 Drugs Class I - Dangerous
Labeling mix-up - Indications on product label are incorrect.
💊 Drugs Class I - Dangerous
SubPotent Drug: Low out-of-specification results for assay testing.
Advil Liqui-Gel Mini 160+20+20 CT (e-commerce) NDC # 0573-1715-59 SKU# F00573171559 (original lot # R53074) Co-packaged Batch/Lot # 0198FR & 3188FRB
Glaxosmithkline Consumer Healthcare Holdings
💊 Drugs Class I - Dangerous
Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel.
Ibuprofen 50 mg per 1.25 mL Oral Suspension Advil Infant Concentrated Drops White Grape 0.75 oz. and 1 oz. bottles NDC 0573-0191-75 (0.75 oz.) NDC 0573-0191-50 (1 oz.)
Glaxosmithkline Consumer Healthcare Holdings
💊 Drugs Class I - Dangerous
Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel.
Medtronic MiniMed Paradigm Insulin pump, model number MMT-723
Medtronic MiniMed
🏥 Medical Devices Class I - Dangerous
The action is being initiated due to potential cybersecurity vulnerabilities related to a series of insulin pumps that are designed to communicate using a wireless radio frequency (RF). An unauthorized person could potentially connect wirelessly to a nearby insulin pump to change settings and control insulin delivery.
Medtronic MiniMed Paradigm Insulin pump, model number MMT-523K
Medtronic MiniMed
🏥 Medical Devices Class I - Dangerous
The action is being initiated due to potential cybersecurity vulnerabilities related to a series of insulin pumps that are designed to communicate using a wireless radio frequency (RF). An unauthorized person could potentially connect wirelessly to a nearby insulin pump to change settings and control insulin delivery.
Precision Xtra Blood Glucose & Ketone Monitoring System, UDI: 00093815715023, 00093815988144
Abbott Diabetes Care
🏥 Medical Devices Class I - Dangerous
Instructions sent in a letter or in instructions for use for disinfecting blood glucose and/or ketone meters were distributed but not cleared by the U.S. FDA, and devices were not cleared for multiple-patient use. Instructions could lead to inappropriate meter disinfection or improper handling of contaminated meters, which may cause infection or exacerbation of an existing infection.
Imager II 5F Angiographic Catheters, 5 units per package.
Boston Scientific
🏥 Medical Devices Class I - Dangerous
Potential for tip detachment of Imager II 5F Angiographic Catheters
ev3 Pipeline Flex Embolization Device. For neurological endovascular use.
Micro Therapeutics Inc
🏥 Medical Devices Class I - Dangerous
Embolization device delivery system may fracture at the distal section during device implantation. A weakened bond may result in unintended separation, where the distal portion of the device delivery system remains in the patient. If a Pipeline Flex embolization device has already been implanted successfully, there is no increased risk to patients due to this issue.
🏥 Medical Devices Class I - Dangerous
The company identified potential interference from hydroxyurea. Patient use of the anti-neoplastic drug may falsely elevate glucose readings on the Continuous Glucose Monitoring Systems.
Skytron Ergon 3 Series Skyboom Monitor Bracket-Flatscreen Bracket, single monitor mount, 27" max. screen size Part number 3FCM1
Skytron, Div. The KMW Group
🏥 Medical Devices Class I - Dangerous
Potential for the weld to fail at the pivot point of the monitor bracket. This weld failure could cause the display interface and bracket to fall from its mounted location, resulting in injury.
🏥 Medical Devices Class I - Dangerous
It is possible that the collimators have screw hole locations that were insufficiently tapped. There is a potential for the collimator assembly to fall and come into contact with a patient or operator.