11,815 recalls · Class II, newest first
Reason CGMP Deviation: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity…
Reason CGMP Deviation: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity…
Reason CGMP Deviation: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity…
Reason CGMP Deviations
Reason CGMP Deviations
Reason Short fill: Complaints received of less fill volume in respule and few drops of liquid observed in the intact pouch.
Reason Lack of assurance of sterility: bags have the potential to leak..
Reason Subpotent Drug
Reason cGMP Diviations
Reason Failed Dissolution Specifications
Reason Lack of assurance of sterility: pinholes, within the blue label characters on the EXCEL bag, specifically within the dotted characters on the label…
Reason Lack of Assurance of Sterility: Out of specification for volume and compromised container closure.
Reason Failed Stability Specification: Water determination was found not complying with specification.
Reason CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
Reason CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
Reason CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
Reason CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
Reason CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
Reason Failed Impurities/Degradation Specifications: Out-of-specification test results.
Reason CGMP Deviations: Product was stored outside labeled storage temperature requirements. Product was exposed to controlled room temperature environment…
Reason Failed Stability Specifications: Out of specification for blend uniformity.
Reason an out of specification result obtained during routine stability testing for Impurities. There is a remote possibility that use of this product…
Reason cGMP Deviations: Products were stored outside the drug label specifications.
Reason cGMP Deviations: Products were stored outside the drug label specifications.
Reason cGMP Deviations: Products were stored outside the drug label specifications.