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 55 mg pellets in Nevada due to a non-approved sterilization method.
Partell Specialty Pharmacy is recalling Lipoic Acid 25mg/mL vials in Nevada because the firm used a non-approved method of sterilization.
Partell Specialty Pharmacy is recalling Estradiol 50 mg pellets in Nevada due to a non-approved sterilization method.
Partell Specialty Pharmacy is recalling Estradiol 35 mg pellets in Nevada due to the use of a non-approved sterilization method.
Partell Specialty Pharmacy is recalling specific lots of Testosterone/Anastrozole pellets in Nevada due to a non-approved sterilization method.
Partell Specialty Pharmacy is recalling TM #6 drug products in Nevada due to a non-approved method of sterilization.
Partell Specialty Pharmacy is recalling Testosterone Propionate 100mg/mL vials because a non-approved method of sterilization was used.
Partell Specialty Pharmacy is recalling specific testosterone and hormone pellet vials because they were sterilized using a non-approved method.
Partell Specialty Pharmacy is recalling specific lots of B-complex injectable vials because a non-approved sterilization method was used.
Partell Specialty Pharmacy is recalling Biotin Suspension 10mg/mL vials because they were sterilized using a non-approved method.
Partell Specialty Pharmacy is recalling TM #3 drug vials because they were sterilized using a non-approved method, raising concerns about sterility assurance.
Partell Specialty Pharmacy is recalling Estradiol 25 mg pellets in Nevada because they were sterilized using a non-approved method.
Partell Specialty Pharmacy is recalling Vitamin D 50,000 unit/ml injectable liquid because it was sterilized using a non-approved method.
Partell Specialty Pharmacy is recalling Testosterone/Anastrozole pellets in Nevada because they were sterilized using a non-approved method.
Partell Specialty Pharmacy is recalling Naltrexone 200 mg pellets because a non-approved sterilization method was used, creating a lack of assurance of sterility.
Partell Specialty Pharmacy is recalling Testosterone 50 mg pellets because they were sterilized using a non-approved method.
Partell Specialty Pharmacy is recalling specific vials of a methionine, inositol, choline, and B12 combination drug due to a non-approved sterilization method.
Partell Specialty Pharmacy is recalling MVI-7 injectable vials because a non-approved sterilization method was used, raising concerns about product sterility.
Partell Specialty Pharmacy is recalling Estradiol 40 mg pellets in Nevada due to a non-approved sterilization method.
Partell Specialty Pharmacy is recalling Testosterone/Finasteride 80 mg/8 mg pellets because a non-approved method of sterilization was used.
Partell Specialty Pharmacy is recalling Estradiol 20 mg pellets in Nevada because a non-approved sterilization method was used.
Partell Specialty Pharmacy is recalling Estradiol 15 mg pellets in Nevada due to a non-approved sterilization method.
Partell Specialty Pharmacy is recalling four vials of Glutathione 200mg/mL in Nevada because the products were sterilized using a non-approved method.
Partell Specialty Pharmacy is recalling Testosterone 55 mg pellets in Nevada because they were sterilized using a non-approved method.
Partell Specialty Pharmacy is recalling 7 vials of Testosterone Cypionate 200mg/mL in Nevada because the firm used a non-approved method of sterilization.