92,900 total recalls in our database
Breckenridge Pharmaceutical
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Lack of assurance of sterility. Bacterial contamination detected in some media fill units
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
CGMP Deviations
Lack of assurance of sterility. Bacterial contamination detected in some media fill units
Lack of assurance of sterility. Bacterial contamination detected in some media fill units
cGMP deviations
cGMP deviations
cGMP deviations
Superpotent Drug: Assay/potency result for hydromorphone HCl in the compounded stability lot was higher than specification..
Lack of Assurance of Sterility: Leaking/damaged syringes.
Failed Impurities/Degradation Specifications: an out of specification result observed in degradation product test (any unspecified degradation product) during 18-month long term stability study.
Denver Solutions, LLC
Lack of Assurance of Sterility: Leaking/damaged syringes.
Denver Solutions, LLC
Lack of Assurance of Sterility: Leaking/damaged syringes.
CGMP Deviations
Denver Solutions, LLC
Lack of Assurance of Sterility: Leaking/damaged syringes.
cGMP deviations
CGMP Deviations
Device may have a small breach in the proximal end of the shaft under the strain relief of the delivery system. Breach is not visibly detectable and may lead to prolonged procedure, blood loss, or air ingress with potential for air embolism.
Merit Medical Systems
Update to IFU to provide additional information related to risk with device over-rotation and multiple deployment of fasteners.