Tivicay (dolutegravir)
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.
18,003 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.
CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits.
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 .
Subpotent Drug: FDA analysis has revealed some bottles of these products were sub potent for ethanol.
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.
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.
Lack of assurance of sterility.
Lack of assurance of sterility.
Lack of assurance of sterility.