Coast Quality Pharmacy, LLC dba Anazao Health Fentanyl Citrate and Clonidine HCL and recall — FDA D-0605-2020
Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.
Browse U.S. drug recall enforcement reports from the FDA in a structured, searchable format. Review the recalled product, reason, firm, status, dates, distribution information and FDA classification when available.
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Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.
Defective delivery system; product is not foaming or is coming out as liquid.
Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.
Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.
Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Cross contamination with other products: undeclared contaminants of phenol and camphor in petroleum jelly tubes.
Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.
Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.
Labeling: Label Error on Declared Strength; cases labelled Mirtazapine 15mg tablets, 500-count bottles, contain 500-count bottles of Mirtazapine 15mg tablets labelled as Mirtazapine 7.5 mg…
Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.
Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.
Defective delivery system; product is not foaming or is coming out as liquid.
Presence of Foreign Substance: Presence of a foreign object in a single tablet.
Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.
Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
CGMP Deviations: Presence of NDMA impurity detected in product.
Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Discoloration; Hazy solution found in one vial instead of a clear solution.
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