FDA (Drugs) recall action 79619
The FDA (Drugs) publishes a recall like this one as 49 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 49 pages.
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
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.
Partell Specialty Pharmacy is recalling Estradiol 12.5 mg pellets in Nevada due to a non-approved sterilization method.
Partell Specialty Pharmacy is recalling Ascorbic Acid (Tapioca) 500 mg/mL vials because they were sterilized using a non-approved method.
Partell Specialty Pharmacy is recalling 11 vials of Methionine/Inositol/Choline in Nevada due to a non-approved sterilization method.
Partell Specialty Pharmacy is recalling CoEnzymeQ10 25mg/mL vials because they were sterilized using a non-approved method.
Partell Specialty Pharmacy is recalling Testosterone 100 mg pellets in Nevada because they were sterilized using a non-approved method.
Partell Specialty Pharmacy is recalling TM #4 drug products because a non-approved method of sterilization was used.
Partell Specialty Pharmacy is recalling Nandrolone decanoate 200mg/mL vials because they were sterilized using a non-approved method.
Partell Specialty Pharmacy is recalling specific lots of Progesterone 50 mg pellets in Nevada because the products were sterilized using a non-approved method.
Partell Specialty Pharmacy is recalling Testosterone 25 mg pellets because they were sterilized using a non-approved method.
Partell Specialty Pharmacy is recalling Testosterone/Anastrozole pellets because they were sterilized using a non-approved method.
Partell Specialty Pharmacy is recalling Methylcobalamin 12.5 mg/mL Injectable Liquid in Nevada due to a non-approved method of sterilization.
Partell Specialty Pharmacy is recalling Estradiol 10 mg pellets in Nevada due to a non-approved sterilization method.
Partell Specialty Pharmacy is recalling HCG 1000 units/mL vials in Nevada because a non-approved sterilization method was used.
Partell Specialty Pharmacy is recalling Testosterone/Finasteride/Anastrozole pellets because they were sterilized using a non-approved method.
Partell Specialty Pharmacy is recalling Testosterone 200 mg pellets in Nevada because they were sterilized using a non-approved method.
Partell Specialty Pharmacy is recalling Testosterone/Anastrozole pellets because a non-approved sterilization method was used, raising concerns about sterility assurance.
Partell Specialty Pharmacy is recalling Testosterone 80 mg pellets in Nevada because they were sterilized using a non-approved method.
Partell Specialty Pharmacy is recalling Methionine 25mg/Inositol 50mg/Choline 50mg/B12 1mg injections because they were sterilized using a non-approved method.
Partell Specialty Pharmacy is recalling Pregnenolone 100 mg pellets because they were sterilized using a non-approved method.
Partell Specialty Pharmacy is recalling TM #1 Injectable solution because a non-approved sterilization method was used. The product was distributed only in Nevada.
Partell Specialty Pharmacy is recalling Testosterone 40 mg pellets in Nevada due to a non-approved sterilization method.
Partell Specialty Pharmacy is recalling Testosterone 37.5 mg pellets because they were sterilized using a non-approved method.
Partell Specialty Pharmacy is recalling Testosterone/Finasteride pellets because they were sterilized using a non-approved method.
Partell Specialty Pharmacy is recalling specific lots of TM drug vials because they were sterilized using a non-approved method.