💊 Drugs Class I - Dangerous
Failed Dissolution Specifications.
All Recalls
95,050 total recalls in our database
Temozolomide Capsules, 5 mg, packaged in a) 5-count bottle (NDC 67877-537-07), b) 14-count bottle (NDC 67877-537-14), Rx only, Manufactured by: Deva Holding A.S., 1 Merkez Mahallesi, Istanbul, Turkey 34303, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054.
Deva Holding AS - Cerkezkoy Subesi
💊 Drugs Class I - Dangerous
CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.
💊 Drugs Class I - Dangerous
cGMP Deviations: Products may have microbial contamination.
💊 Drugs Class I - Dangerous
CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
💊 Drugs Class I - Dangerous
CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
💊 Drugs Class I - Dangerous
Failed Content Uniformity Specifications: Out-of-specification result observed in uniformity of containers test at 9 month long term stability condition for upright orientation.
0.9% Sodium Chloride Injection USP, 100 mL Viaflex Container, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015, USA, NDC 0338-0049-38.
Baxter Healthcare
💊 Drugs Class I - Dangerous
Lack of Assurance of Sterility: Bags have potential to leak.
💊 Drugs Class I - Dangerous
cGMP Deviations: Products may have microbial contamination.
💊 Drugs Class I - Dangerous
cGMP Deviations: Products may have microbial contamination.
💊 Drugs Class I - Dangerous
CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
💊 Drugs Class I - Dangerous
CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
💊 Drugs Class I - Dangerous
Failed Dissolution Specifications
💊 Drugs Class I - Dangerous
CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
BrightView XCT , Model Number 882482
Philips Medical Systems (Cleveland)
🏥 Medical Devices Class I - Dangerous
An issue with the handcontroller may result in either spontaneous uncommanded motions or continued motion after the buttons were released.
Terumo Sur-vet Needle, 25G x 5/8", Product Code 100280
Terumo Medical
🏥 Medical Devices Class I - Dangerous
There is a potential for a loss of package integrity that may compromise the sterility of the product.
AXIOM Artis dTC, Model Number 7413078
Siemens Medical Solutions USA
🏥 Medical Devices Class I - Dangerous
A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube will not be supplied with the required voltage and X-ray will not be possible. The issue occurs sporadically; however, it may occur during an on-going procedure.
Terumo Needle, 23G x 1", Product Code NN2325R
Terumo Medical
🏥 Medical Devices Class I - Dangerous
There is a potential for a loss of package integrity that may compromise the sterility of the product.
Merge OrthoPACS versions 7.3, 7.3.1, 8.0 and 8.0.1
Merge Healthcare
🏥 Medical Devices Class I - Dangerous
Potential for prior thumbnails to not display in reverse chronological order and images may not scroll in reverse chronological order when mammography stacked scrolling is enabled. Merge PACS provides image manipulation tools to enable users to view and compare images such as: linking, MPR, MIP, 3D image fusion/registration of CT, MR and PET; as well as CVR (Color Volume Rendering), measurements (linear distances, angles, areas, SUV, etc.), and annotations (for example, outline and label regions of interest, label spinal vertebrae).
Terumo Sur-vet Needle, 20G x 1", Product Code 100204
Terumo Medical
🏥 Medical Devices Class I - Dangerous
There is a potential for a loss of package integrity that may compromise the sterility of the product.
3mL Luer-Lok Syringe, Catalog Number 309657, UDI 30382903096573
Becton Dickinson & Company
🏥 Medical Devices Class I - Dangerous
The syringes have scale markings that were printed incorrectly. The scale is skewed to varying degrees, resulting in missing and/or partially printed scale numbers and scale lines.