💊 Drugs Class I - Dangerous
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
All Recalls
95,064 total recalls in our database
💊 Drugs Class I - Dangerous
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
💊 Drugs Class I - Dangerous
Failed stability specifications: Out of specification for hardness test
💊 Drugs Class I - Dangerous
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Nebivolol Tablets, 20 mg, 90 Tablets, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for Avkare, Pulaski, TN 38478, Product of Italy, NDC 42291-874-90.
Glenmark Pharmaceuticals Inc., USA
💊 Drugs Class I - Dangerous
Cross Contamination with Other Products
Tropicamide 1%/Cyclopentolate 1%/Phenylephrine 2.5%/Ketorolac 0.5% Topical Ophthalmic Solution, 0.5mL Single-Use Syringe, For Topical Ophthalmic Use Only. Not for IV Use. Fagron Sterile Services, 8710 E 34th St N, Wichita, KS 67226. NDC: 71266-8240-01
Fagron Compounding Services
💊 Drugs Class I - Dangerous
Incorrect Product Formulation
Quick Strip Fabric Sterile Adhesive Bandages, 1" x 3", Medline Item Number NON25660QS
Medline Industries
🏥 Medical Devices Class I - Dangerous
Medline has identified that all lots of the Curad Touch-Free and Quick-Strip Bandages may exhibit open seals in the packaging which may compromise the sterility of the product.
🏥 Medical Devices Class I - Dangerous
The IFU addendum revises the Preventative Maintenance schedule to align with the update introduced in the Service Manual as of June 2023.
Wire connected to the electrical box may shift out of its intended position, which may result in electrical arcing. Electrical arcing remains internal within the unit (no risk of shock to users).
Wire connected to the electrical box may shift out of its intended position, which may result in electrical arcing. Electrical arcing remains internal within the unit (no risk of shock to users).
🏥 Medical Devices Class I - Dangerous
Labeling discrepancy; Ureteral stent actual size may not match the actual product label.
Labeling contains claims that are not consistently present.
🏥 Medical Devices Class I - Dangerous
Labeling discrepancy; Ureteral stent actual size may not match the actual product label.
🏥 Medical Devices Class I - Dangerous
It has been determined that certain lots of Access 2 Reaction Vessels may contain manufacturing deformities. The bottom (round end) of the Reaction Vessel may have a small protrusion or hair like deformity. This could cause causing instrument errors (e.g., pipetting, rake, wash carousel errors) that could delay patient results.
Quick Strip Fabric Sterile Adhesive Bandages, 0.75" x 3", Medline Item Number NON25650QS
Medline Industries
🏥 Medical Devices Class I - Dangerous
Medline has identified that all lots of the Curad Touch-Free and Quick-Strip Bandages may exhibit open seals in the packaging which may compromise the sterility of the product.
Affected gowns have the incorrect expiration date on the product packaging. Product has a shelf-life of three years which is mislabeled on the product packaging as five (5) years.
🏥 Medical Devices Class I - Dangerous
Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts.
🏥 Medical Devices Class I - Dangerous
The IFU addendum revises the Preventative Maintenance schedule to align with the update introduced in the Service Manual as of June 2023.
🏥 Medical Devices Class I - Dangerous
Labeling discrepancy; Ureteral stent actual size may not match the actual product label.
🏥 Medical Devices Class I - Dangerous
Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts.