1,018 recalls, newest first
Labeling: incorrect or missing lot and/or expiration date. An incorrect expiration date was printed on the product labeling with an expiration date of January 2027, whereas the correct expiration date is September 2026.
CGMP Deviations: Gaps in the quality system in the Quality Control microbiology laboratory.
Failed Dissolution Specifications- Low Out-Of-Specification results obtained during stability testing.
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits .
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits .
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits .
Failed Impurities/Degradation Specifications.
Failed Impurities/Degradation Specifications.
Failed Impurities/Degradation Specifications.
Failed Impurities/Degradation Specifications.
Lack of assurance of sterility
Lack of assurance of sterility
Lack of assurance of sterility
Lack of assurance of sterility
Lack of assurance of sterility
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Superpotent Drug: product complaint for milky blue appearance and consistency, further investigation by the firm found the recalled lots out of specification for the four active ingredients.
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Failed Dissolution Specifications: Sirolimus Oral Solution recalled due to lot RZ1598 exceeded the specification limit at the 14-month timepoint.
Failed Dissolution Specifications: Nitrofurantoin Capsules recalled due to dissolution failure at 0-time of the repackaged lot. Drug release results were above specification at 0-time.
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits.
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits.
Defective container: loose crimp defect, potential loss of container integrity.