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 characteristics that they are purported or represented to possess.
Reason CGMP Deviation: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.
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. The concentration of the reconstituted product is listed as '20 mg per vial.' This information should read: '20 mg per mL'.
Reason Labeling: Incorrect or missing Package Insert: There is an error on the Package Insert (PI), section 2.3, Preparation, Handling, and Administration. The concentration of the reconstituted product is listed as '20 mg per vial.' This information should read: '20 mg per mL'.
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, resulting in leaks.
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.