FDA (Drugs) recall action 71275
The FDA (Drugs) publishes a recall like this one as 12 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 12 pages.
Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection
The agency’s own wording, quoted from the enforcement report.
Montana Compounding Pharmacy is recalling specific lots of Trimix injectable vials because FDA inspectors observed objectionable conditions that raise concerns about sterility.
Montana Compounding Pharmacy is recalling specific lots of Trimix injectable vials because FDA inspectors observed objectionable conditions that raise concerns about sterility.
Montana Compounding Pharmacy is recalling Avastin syringes because FDA inspectors observed objectionable conditions that raise concerns about sterility.
Montana Compounding Pharmacy is recalling specific lots of Trimix injectable vials due to lack of assurance of sterility observed during an FDA inspection.
Montana Compounding Pharmacy is recalling Alprostadil injectable vials due to lack of assurance of sterility and objectionable conditions observed during an FDA inspection.
Montana Compounding Pharmacy is recalling specific lots of Glutathione Nasal Solution because FDA inspectors observed objectionable conditions that raise concerns about the product's sterility.
Montana Compounding Pharmacy is recalling 20 vials of Glutathione Inhalation solution because objectionable conditions were observed during an FDA inspection, raising concerns about sterility.
Montana Compounding Pharmacy is recalling Alprostadil injectable vials because objectionable conditions were observed during an FDA inspection, raising concerns about sterility.
Montana Compounding Pharmacy is recalling Trimix injectable vials because FDA inspectors observed objectionable conditions that raise concerns about the product's sterility.
Montana Compounding Pharmacy is recalling Alprostadil injectable vials due to lack of assurance of sterility and objectionable conditions observed during an FDA inspection.
Montana Compounding Pharmacy is recalling Hyaluronidase Injectable Solution because FDA inspectors observed objectionable conditions that raised concerns about the product's sterility.
Montana Compounding Pharmacy is recalling Bimix injectable vials because FDA inspectors observed objectionable conditions that raise concerns about sterility assurance.