95,083 total recalls in our database
PD-Rx Pharmaceuticals
Failed Tablet/Capsule Specification: out of specification for tablet weight.
Microbial contamination of non-sterile product: product failed Total Yeast/Mold Count specification.
Bayer HealthCare Pharmaceuticals
Defective Container: Confirmed customer compliant of small holes or cracks in the foil of blister packs.
Failed Dissolution Specifications
Hospira a Pfizer Company
Lack of Sterility Assurance
Zydus Pharmaceuticals USA
Failed Dissolution Specifications
Failed Impurities/Degradation Specifications: high out of specification results for related impurity for lot C700220.
Labeling Error: Label mix-up. Products' unit dose cups are correctly labeled, but the product carton lists incorrect volume and NDC.
Fusion IV Pharmaceuticals, Inc.
CGMP Deviations
Failed Dissolution Specifications
Teva Pharmaceuticals USA
Failed Tablet/Capsule Specification; out of specification for tablet weight
Hospira a Pfizer Company
Lack of Sterility Assurance
Microbial contamination of non-sterile product: product failed Total Yeast/Mold Count specification.
Failed Impurities/Degradation Specifications: high out of specification results for related compound D.
Labeling; Label Mix up; cartons labeled as Amantadine HCl 100 mg Capsules contain unit dose blister cards of Cyclobenzaprine HCl Tablet, USP 5 mg
Sorin Group USA
Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged in pouches which may have small pinholes (approximately 1mm or less in diameter). The result is a potential sterile barrier breach in the display sets. These display sets are included with LivaNova Perfusion Tube Sets (PTS) which were then distributed to customers.
Stryker Neurovascular
Stryker Neurovascular has become aware that some 3-Pack Stroke Fast Packs were manufactured using a carton sleeve where the pre-printed contents on the back of the sleeve did not match the physical contents of the pack.
Sorin Group USA
Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged in pouches which may have small pinholes (approximately 1mm or less in diameter). The result is a potential sterile barrier breach in the display sets. These display sets are included with LivaNova Perfusion Tube Sets (PTS) which were then distributed to customers.
A Tomcat Instrument software anomaly that causes the pipettor arm to make physical contact with the mucous shelf which could potentially lead to incorrect patient results.
Complaint of the head holder connector locking up mechanically when tightened.