Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches.
All Recalls
95,064 total recalls in our database
Synjardy (empagliflozin and metformin hydrochloride) Tablets. 5 mg/1000 mg. Rx only. 180-count bottle. Distributed by: Boehinger Ingelheim (BI) Pharmaceuticals, Inc. Ridgefield, CT 06877. Made in Germany. Marketed by: BI Pharmaceuticals, Inc. Ridgefield, CT 06877 and Eli Lilly and Company Indianapolis IN 46285 NDC 0597-0175-18
Boehringer Ingelheim Pharmaceuticals
Cross Contamination With Other Products:
Discoloration: A complaint was received from a pharmacist for the presence of blue specks on tablets.
Failed Impurities/Degradation Specifications: OOS for unknown impurities.
Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches.
Zoledronic Acid Injection, 5mg/100 mL (0.05 mg/mL) 100ml vial, Rx Only. Mfd By: Gland Pharma Limited D.P. Pally - 500 043 India: Mfd. For: Dr. Reddy's Laboratories Limited Bachupally - 500 090 India. NDC 55111-688-52
Dr. Reddy's Laboratories
Failed Impurities/Degradation Specifications: OOS for unknown impurities.
Montelukast Sodium Tablets 10 mg, 30-count bottle, Rx Only, By: Hetero Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar - 509 301, India, Manfuactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854, NDC 31722-726-30
Hetero Labs Limited Unit V
Labeling: Label Mix-Up - One lot labeled Montelukast Sodium Tablets 10 mg tablets may contain 90 tablets of Losartan Potassium 50 mg.
Fenofibrate Tablets, USP 145 mg, 90-count bottles, Rx only, Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ, 08854, NDC 31722-596-90
Hetero Labs, Ltd. - Unit III
Presence of Foreign Tablet/Capsule: A foreign identified as Valacyclovir tablet 500 mg was co-mingled in a bottle containing Fenofibrate Tablets, USP 145 mg.
Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution.
Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches.
AIIuraXperFDlO/10, System Code 722011 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions
Philips Electronics North America
There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may detach from the actuator rotor shaft causing the monitor to fall from the ground. When a Monitor Ceiling Suspension detaches from the actuator rotor shaft and the monitor falls, there is a risk of injury for the patient, user and bystander.
HipLOC System Plate Barrel due to an undersized bore on the HipLOC plate barrel, can result in the lag screw not fitting through the barrel
There is a possibility that the seal of the sterile pouch may be compromised, thereby increasing the risk of infection.
INTEGRIS CV, System Code 722030 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions
Philips Electronics North America
There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may detach from the actuator rotor shaft causing the monitor to fall from the ground. When a Monitor Ceiling Suspension detaches from the actuator rotor shaft and the monitor falls, there is a risk of injury for the patient, user and bystander.
Allura Xper FD1O C, System Code 722001 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions
Philips Electronics North America
There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may detach from the actuator rotor shaft causing the monitor to fall from the ground. When a Monitor Ceiling Suspension detaches from the actuator rotor shaft and the monitor falls, there is a risk of injury for the patient, user and bystander.
Poly C- DMCP-Visub(H3000), System Code 72238 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions
Philips Electronics North America
There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may detach from the actuator rotor shaft causing the monitor to fall from the ground. When a Monitor Ceiling Suspension detaches from the actuator rotor shaft and the monitor falls, there is a risk of injury for the patient, user and bystander.
HipLOC System Plate Barrel due to an undersized bore on the HipLOC plate barrel, can result in the lag screw not fitting through the barrel
GE Medical Systems has discovered a small area on the bore surface of the Discovery MR750w Nuclear Magnetic Resonance Imaging System, normally accessible to the patient, can get warm enough to cause a serious burn in the event the patient touches the bore and proper padding is not used.
VALITUDE X4 CRT-P (Cardiac Resynchronization Therapy Pacemaker)
Boston Scientific
Boston Scientific has identified a subset of active pacemaker and CRT-Ps systems with an elevated potential for early pacemaker replacement due to hydrogen-induced accelerated battery depletion.
The back cap separates from the body of the vitrectomy cutter.