17,898 recalls, newest first
Reason CGMP Deviations: The recalling firm filed for Chapter 11 in September 2024. As a result, it cannot monitor the quality program and hence cannot assure that products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess, rendering the products adulterated.
Reason Subpotent drug
Reason CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Reason CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Reason Failed Stability Specifications: Out of specification results was observed in Induction Port during the analysis of Particle size distribution at the 12-month time point.
Reason Lack of Assurance of Sterility.
Reason Failed Impurities/Degradation Specifications: An out-of-Specification for total related compounds
Reason cGMP Deviations
Reason Failed Dissolution Specifications: potential for delayed dissolution of the dose after administration which may result in delayed release of the drug, delaying onset of sleep.
Reason Failed Dissolution Specifications: low dissolution results
Reason Lack of Processing Controls.
Reason Lack of Processing Controls.
Reason Lack of Processing Controls.
Reason Lack of Processing Controls.
Reason Lack of Processing Controls.
Reason Lack of Processing Controls.
Reason Lack of Processing Controls.
Reason Lack of Processing Controls.
Reason Lack of Processing Controls.
Reason Lack of Processing Controls.
Reason Lack of Processing Controls.
Reason Lack of Processing Controls.
Reason Lack of Processing Controls.
Reason Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia.
Reason Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia.