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Prescription drugs recalled for contamination, potency or labelling.
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1,991 recalls · newest first
CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
Lack of Assurance of Sterility
CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Subpotent drug
CGMP Deviations: The recalling firm filed for Chapter 11 in September 2024.
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Failed Stability Specifications: Out of specification results was observed in Induction Port during the analysis of Particle size distribution at the…
Lack of Assurance of Sterility.
Failed Impurities/Degradation Specifications: An out-of-Specification for total related compounds
Failed Dissolution Specifications: potential for delayed dissolution of the dose after administration which may result in delayed release of the…
Failed Dissolution Specifications: low dissolution results
cGMP Deviations
Lack of Processing Controls.
Lack of Processing Controls.
Lack of Processing Controls.
Lack of Processing Controls.