💊 Drugs Class I - Dangerous
Labeling: Missing label: Label missing from some prefilled pens.
All Recalls
95,018 total recalls in our database
💊 Drugs Class I - Dangerous
FAILED DISSOLUTION SPECIFICATIONS
💊 Drugs Class I - Dangerous
Presence of particulate matter: particulate identified as a beetle.
💊 Drugs Class I - Dangerous
Failed Dissolution Specifications: Failure occurred during routine stability testing of dissolution test.
Nifedipine WSP 0.2% Ointment, 60 gram tubes, Rx only, Valor Compounding Pharmacy, 2461 Shattuck Ave., Berkeley, CA 94704
Valor Compounding Pharmacy, Inc
💊 Drugs Class I - Dangerous
Subpotent and Superpotent Drug
💊 Drugs Class I - Dangerous
Failed Dissolution Specifications
Irbesartan Tablets, USP, 75 mg, 90- count bottle, Rx only, Manufactured by: Jubilant Generics Ltd. Roorkee- 247661, India, Marketed by: Jubilant Cadista Pharmaceuticals Inc. Salisbury, MD 21801, USA, NDC 59746-447-90
Jubilant Cadista Pharmaceuticals
💊 Drugs Class I - Dangerous
Failed Dissolution Specifications
💊 Drugs Class I - Dangerous
Failed Dissolution Specifications
Irbesartan Tablets, USP, 150mg, 90- count bottles, Rx only, Manufactured by: Jubilant Generics Ltd. Roorkee- 247661, India, Marketed by: Jubilant Cadista Pharmaceuticals Inc. Salisbury, MD 21801, USA, NDC 59746-448-90
Jubilant Cadista Pharmaceuticals
💊 Drugs Class I - Dangerous
Failed dissolution specifications.
Centricity PACS Software Version 7.0 SP0.0.4.7
GE Healthcare
🏥 Medical Devices Class I - Dangerous
The Event Notification Manager (ENM) functionality for certain products does not process notifications for study modifications performed on post verified exams.
AquaC UNO H [120V, 60Hz, 1700VA, Fresenius US-Version: 24-0970-1 Vivonic Part Number: G02000966-US
Fresenius Medical Care Holdings
🏥 Medical Devices Class I - Dangerous
Internal ethernet cable may be misaligned, the cable jacket (insulation) could become compromised due to high temperature and result in the internal ethernet cable conducting electrical current to the ethernet port on the outside of the device), potentially harming service technicians and/or other authorized operators. If the ethernet port on the device is touched or manipulated, there is a risk of electrical shock
Sight OLO, Automated Hematology Analyzer, Catalog No. OLO-U1
SIGHT DIAGNOSTICS
🏥 Medical Devices Class I - Dangerous
The default reference ranges for MCH, MCHC, and RDW for age group "Child 2-11y" are mixed up and incorrectly displayed on OLO devices running software version 2.63, 2.63.1, and 2.63.1.1. Due to the issue, results may incorrectly appear to be within or outside the reference range.
Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D)
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
🏥 Medical Devices Class I - Dangerous
Manufacturing error that may have resulted in a cathode component being out of specification. All devices met final functional testing requirements.
🏥 Medical Devices Class I - Dangerous
Kits contain leaking bottles of isopropyl alcohol
REF: 08P4377, Alinity c Hemoglobin Reagent Kit, IVD, CE, R1 5 x 46.0 mL, R2 5 x 18.3 mL, A1cDL 5 x 67.6 mL
Abbott Laboratories
🏥 Medical Devices Class I - Dangerous
There is a potential for falsely elevated Hemoglobin %A1c and Hemoglobin A1c results to be generated using the ARCHITECT and Alinity c Hemoglobin A1c assay.
🏥 Medical Devices Class I - Dangerous
Due to Titanium plasma coating not present implant.
REF: 4P52-20 Hemoglobin A1c for use with Architect, IVD, CE, R1 1 x 52 mL, R2 1 x 20 mL, A1cDL 2 x 35 mL
Abbott Laboratories
🏥 Medical Devices Class I - Dangerous
There is a potential for falsely elevated Hemoglobin %A1c and Hemoglobin A1c results to be generated using the ARCHITECT and Alinity c Hemoglobin A1c assay.
🏥 Medical Devices Class I - Dangerous
Kits contain leaking bottles of isopropyl alcohol
REF: 08P4320, Alinity c Hemoglobin Reagent Kit, IVD, CE, R1 5 x 46.0 mL, R2 5 x 18.3 mL, A1cDL 5 x 67.6 mL
Abbott Laboratories
🏥 Medical Devices Class I - Dangerous
There is a potential for falsely elevated Hemoglobin %A1c and Hemoglobin A1c results to be generated using the ARCHITECT and Alinity c Hemoglobin A1c assay.
nordicBrainEX, software versions 2.21 through 2.3.10
NordicNeuroLab AS
🏥 Medical Devices Class I - Dangerous
When exporting merged results from the BOLD, DSC, and DCE modules of nordicBrainEx, where both the underlay and overlay originated from a multiframe dataset, the resulting output may have left/right sides flipped.