Every FDA drug recall whose status is still Ongoing: the firm is still removing product from the market, or the FDA has not yet closed the file. Some were opened years ago and never formally terminated, so check the initiation date as well as the status.
2,760 recalls, newest first.
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.
Subpotent drug
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
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.
Lack of Assurance of Sterility.
Failed Impurities/Degradation Specifications: An out-of-Specification for total related compounds
cGMP Deviations
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.
Failed Dissolution Specifications: low dissolution results
Lack of Processing Controls.
Lack of Processing Controls.
Lack of Processing Controls.
Lack of Processing Controls.
Lack of Processing Controls.
Lack of Processing Controls.
Lack of Processing Controls.
Lack of Processing Controls.
Lack of Processing Controls.
Lack of Processing Controls.
Lack of Processing Controls.
Lack of Processing Controls.
Lack of Processing Controls.
Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia.
Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia.