FDA (Drugs) recall action 81346
The FDA (Drugs) publishes a recall like this one as 14 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 14 pages.
Lack of Assurance of Sterility
The agency’s own wording, quoted from the enforcement report.
Qualgen, LLC is recalling specific lots of Testosterone 50mg pellets nationwide due to a lack of assurance of sterility.
Qualgen, LLC is recalling specific lots of Testosterone 37.5 mg pellets nationwide due to a lack of assurance of sterility.
Qualgen, LLC is recalling Estradiol 18mg pellets because the company cannot assure the sterility of the product. The recall covers specific vial sizes distributed nationwide.
Qualgen, LLC is recalling Estradiol 25mg pellets because the company cannot assure the sterility of the product. The recall covers specific lots distributed nationwide.
Qualgen, LLC is recalling Testosterone 12.5mg pellets nationwide because the sterility of the product cannot be assured. Consumers should stop using the affected lots and contact the manufacturer or pharmacist.
Qualgen, LLC is recalling specific lots of Testosterone 25 mg pellets nationwide because the company lacks assurance of sterility for these products.
Qualgen, LLC is recalling Estradiol 12.5mg pellets nationwide because the company cannot ensure the product is sterile.
Qualgen, LLC is recalling Estradiol 10mg pellets nationwide due to a lack of assurance of sterility. The affected lots have specific expiration dates.
Qualgen, LLC is recalling specific lots of Testosterone 100mg pellets nationwide due to a lack of assurance of sterility.
Qualgen, LLC is recalling Estradiol 15mg pellets because the company cannot ensure the products are sterile. The recall covers specific lots distributed nationwide.
Qualgen, LLC is recalling Estradiol 6 mg pellets nationwide because the company cannot ensure the product is sterile.
Qualgen, LLC is recalling specific lots of Testosterone 200mg pellets nationwide due to a lack of assurance of sterility.
Qualgen, LLC is recalling Testosterone 200 mg/Anastrozole 20 mg pellets due to a lack of assurance of sterility. The recall affects specific vial sizes distributed nationwide.
Qualgen, LLC is recalling specific lots of Testosterone 87.5mg pellets nationwide due to a lack of assurance of sterility.