95,102 total recalls in our database
Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
Failed Impurities/Degradation Specifications: OOS result was obtained for Any Other Individual Impurity at the 12M room temperature time point.
Failed Dissolution Specifications: low out of specification results for dissolution.
Presence Of Foreign Substance: Customer complaint for the presence of dark, gritty substance found within the bottle which was determined to be activated carbon from the desiccant canister inside the bottle.
Subpotent Drug
Presence Of Foreign Substance: Customer complaint for the presence of dark, gritty substance found within the bottle which was determined to be activated carbon from the desiccant canister inside the bottle.
Subpotent Drug
Defective container: loose crimp defect, potential loss of container integrity.
Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
Failed Impurities/Degradation Specifications: OOS result was obtained for Any Other Individual Impurity at the 12M room temperature time point.
Subpotent Drug
Microbial Contamination of Non-Sterile Product: Product is contaminated with Burkholderia gladioli.
Subpotent Drug
Karl Storz Endoscopy
Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.
Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.
Woodside Acquisitions
Firm distributed tests which have not been cleared or authorized for marketing or distribution in the United States.
bioMerieux
Software issue where results sent to the LIS via HL7 format for antibiotic screen tests and synergy tests do not include the user-corrected or AES-corrected interpretation. This can potentially lead to incorrect final screen/synergy test results at the LIS.
Olympus Corporation of the Americas
Bronchofiberscope Updated instructions on the use of certain chemicals to be used for reprocessing, conditions for ETO gas sterilization, rinsing steps after high-level disinfection, and a recommendation on using sterilization
FDA review concluded that the test is insufficiently supported by clinical performance data, and results reported may not have been accurate (false positives or false negatives).
DePuy Synthes Radial Head Replacement System Contraindications added to Electronic Instructions for Use (e-IFU): Absolute contraindications include: Infection, sepsis, osteomyelitis.
Olympus Corporation of the Americas
Bronchofiberscope Updated instructions on the use of certain chemicals to be used for reprocessing, conditions for ETO gas sterilization, rinsing steps after high-level disinfection, and a recommendation on using sterilization
Medtronic Vascular
Packaging for Balloon Catheters may be damaged resulting in loss of sterility.