14,801 recalls, 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 Marketed Without An Approved NDA/ANDA
Reason Labeling: Incorrect or missing Package Insert: There is an error on the Package Insert (PI), section 2.3, Preparation, Handling, and Administration…
Reason Labeling: Incorrect or missing Package Insert: There is an error on the Package Insert (PI), section 2.3, Preparation, Handling, and Administration…
Reason CGMP Deviations
Reason Microbial contamination of a non-sterile product: potential Bacillus cereus contamination.
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 Failed Impurities/Degradation Specifications
Reason Lack of assurance of sterility: bags have the potential to leak..
Reason Superpotent Drug: Due to overfilling of drug powder
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 Cross Contamination with Other Products:(mycophenolate mofetil).
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.