💊 Drugs Class I - Dangerous
Failed Tablets/Capsules specifications; missing/broken/extra tablets within the capsules
All Recalls
95,114 total recalls in our database
💊 Drugs Class I - Dangerous
MARKETED WITHOUT AN APPROVED NDA/ANDA: Product found to be tainted with metformin and glyburide
💊 Drugs Class I - Dangerous
Failed Dissolution Specifications
LET Gel (Lidocaine HCL/Epinephrine Bitartrate/Tetracaine HCL 4%/0.18%/0.5% Topical Gel), Single-use Topical Syringe, 3mL syringe, 10/pack, Rx only, Carie Boyd Pharmaceuticals, 8400 Esters Blvd, Ste# 190, Irving, TX 75063, NDC73271-1003-1
Right Value Drug Stores, LLC
💊 Drugs Class I - Dangerous
Product Mix-up: Incorrect Product Formulation
ceFAZolin sodium in Sterile Water for injection, Injectable Solution, 1g/10mL (0.1 g per mL), Syringe, Rx only, Wells Pharma, NDC 73702-131-10
Wells Pharma of Houston
💊 Drugs Class I - Dangerous
Lack of assurance of sterility.
💊 Drugs Class I - Dangerous
Failed Impurities/Degradation Specifications
💊 Drugs Class I - Dangerous
STAQ Pharma Inc. received consumer complaints related to leaking bags and other potential bag concerns. Upon investigation, they determine the source of the issue was with the bag manufacturer who released bags Lot # 134142-001A which had failed internal QC tests for leaks.
💊 Drugs Class I - Dangerous
Failed pH Specifications
💊 Drugs Class I - Dangerous
Crystallization: bottles of Sandimmune Oral Solution were determined to contain crystals
💊 Drugs Class I - Dangerous
Failed Impurities/Degradation Specifications
EVO VISIAN Implantable Collamer Lens, REF: VICMO12.6. Phakic Intraocular lens.
Staar Surgical Company
🏥 Medical Devices Class I - Dangerous
Their is a potential that intraocular implant devices may not meet specifications.
Integra Cranial Access Kit - For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: INS7040
Integra LifeSciences
🏥 Medical Devices Class I - Dangerous
Defect in the outer packaging of the Cranial Access Kits. can cause the packaging to split without any additional forces outside compromising the sterility of the device
🏥 Medical Devices Class I - Dangerous
Elekta has identified that if the microswitch within the middle arm is incorrectly setup, there is a potential for an uncontrolled extension of iViewGT / XVI detector arms. When the detector arm is fully deployed there is no risk of uncontrolled extension.
🏥 Medical Devices Class I - Dangerous
Elekta has identified that if the microswitch within the middle arm is incorrectly setup, there is a potential for an uncontrolled extension of iViewGT / XVI detector arms. When the detector arm is fully deployed there is no risk of uncontrolled extension.
QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-4X3, Order Number G22654; used to dilate strictures of the biliary tree
Wilson-Cook Medical
🏥 Medical Devices Class I - Dangerous
Nonconforming devices while manufactured correctly, do not comply to their design requirements. Potential harms associated with balloon detachment are endoscopic retrieval of an impacted or non-impacted object, bleeding caused by the retrieval device, or the incident can occur without injury and the object is left to pass naturally.
🏥 Medical Devices Class I - Dangerous
Incorrect bonding material used for assembly of the catheter, may fail, resulting in detachment of component parts, broken components, or leakage. This breakage may result in delay of procedure
QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-6X3, Order Number G22655; used to dilate strictures of the biliary tree
Wilson-Cook Medical
🏥 Medical Devices Class I - Dangerous
Nonconforming devices while manufactured correctly, do not comply to their design requirements. Potential harms associated with balloon detachment are endoscopic retrieval of an impacted or non-impacted object, bleeding caused by the retrieval device, or the incident can occur without injury and the object is left to pass naturally.
🏥 Medical Devices Class I - Dangerous
Elekta has identified that if the microswitch within the middle arm is incorrectly setup, there is a potential for an uncontrolled extension of iViewGT / XVI detector arms. When the detector arm is fully deployed there is no risk of uncontrolled extension.
EVO +VISIAN Implantable Collamer Lens, REF: VICM5_13.7.Phakic Intraocular lens.
Staar Surgical Company
🏥 Medical Devices Class I - Dangerous
Their is a potential that intraocular implant devices may not meet specifications.
Stay Safe Cap
Fresenius Medical Care Holdings
🏥 Medical Devices Class I - Dangerous
Updating the labeling to include additional warnings and contraindications for potential side effects.