FDA (Drugs) recall action 83996
The FDA (Drugs) publishes a recall like this one as 31 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 31 pages.
Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Anazao Health is recalling compounded Clonidine, Prialt, and Bupivacaine syringes because environmental sampling detected Talaromyces rotundus, a fungus.
Anazao Health is recalling Glutamine/Arginine/Carnitine vials because environmental sampling detected Talaromyces rotundus, a fungus, indicating a lack of processing controls.
Anazao Health is recalling compounded fentanyl and morphine medications due to the detection of Talaromyces rotundus fungi in environmental samples.
Coast Quality Pharmacy, LLC dba Anazao Health is recalling Clonidine HCL and Morphine Sulfate products due to the presence of Talaromyces rotundus fungi.
Coast Quality Pharmacy is recalling Hydromorphone HCL and Bupivacaine HCL products due to the detection of Talaromyces rotundus fungi during environmental sampling.
Anazao Health is recalling compounded fentanyl and bupivacaine medications due to the presence of Talaromyces rotundus fungi detected during environmental sampling.
Coast Quality Pharmacy, LLC dba Anazao Health is recalling Hydromorphone HCL, Baclofen, and Clonidine HCL combination drugs due to fungal contamination found during environmental sampling.
Coast Quality Pharmacy, LLC dba Anazao Health is recalling Clonidine HCL products because environmental sampling detected Talaromyces rotundus, a fungus.
Anazao Health is recalling Baclofen and Morphine Sulfate because environmental sampling detected Talaromyces rotundus, a fungus, indicating a lack of processing controls.
Anazao Health is recalling Bupivacaine HCl and Hydromorphone HCl products because environmental sampling detected Talaromyces rotundus, a fungus.
Anazao Health is recalling specific lots of Morphine Sulfate, Bupivacaine HCL, and Clonidine HCL because environmental sampling detected Talaromyces rotundus, a fungus.
Coast Quality Pharmacy, LLC dba Anazao Health is recalling compounded sufentanil, clonidine, and bupivacaine syringes because environmental sampling detected Talaromyces rotundus.
Anazao Health is recalling hydromorphone and bupivacaine combination injections due to the presence of Talaromyces rotundus fungi detected during environmental sampling.
Anazao Health is recalling Clonidine HCL/Hydromorphone HCL products because environmental sampling detected Talaromyces rotundus, a fungus, indicating a lack of processing controls.
Anazao Health is recalling compounded fentanyl and morphine drugs after environmental sampling detected Talaromyces rotundus fungi.
Anazao Health is recalling Clonidine HCL and Baclofen products because environmental sampling detected Talaromyces rotundus, a fungus.
Anazao Health is recalling compounded bupivacaine, clonidine, hydromorphone, and fentanyl medications due to the detection of Talaromyces rotundus fungi.
Coast Quality Pharmacy, LLC dba Anazao Health is recalling Morphine Sulfate, Fentanyl Citrate, and Baclofen products due to the detection of Talaromyces rotundus fungi.
Anazao Health is recalling compounded hydromorphone, bupivacaine, baclofen, clonidine, and fentanyl products due to the detection of Talaromyces rotundus fungi.
Coast Quality Pharmacy, LLC dba Anazao Health is recalling Hydromorphone HCL and Clonidine HCL products because environmental sampling detected Talaromyces rotundus, a fungus.
Coast Quality Pharmacy is recalling Hydromorphone HCL because environmental sampling detected Talaromyces rotundus, a fungus.
Anazao Health is recalling Morphine Sulfate and Bupivacaine HCL combination products due to the presence of Talaromyces rotundus fungi.
Coast Quality Pharmacy is recalling Morphine Sulfate and Bupivacaine HCL because environmental sampling detected Talaromyces rotundus, a fungus.
Coast Quality Pharmacy is recalling Bupivacaine, Clonidine, and Hydromorphone injections due to fungal contamination found during environmental sampling.
Anazao Health is recalling Baclofen, Clonidine HCL, and Morphine Sulfate products due to the detection of Talaromyces rotundus fungi during environmental sampling.