FDA (Drugs) recall action 89909
The FDA (Drugs) publishes a recall like this one as 52 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 52 pages.
Lack of Assurance of Sterility
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.
Tailor Made Compounding is recalling 294 vials of Gonadorelin 100mcg/mL distributed nationwide because the manufacturer cannot assure the product meets sterility standards.
Tailor Made Compounding recalls 349 vials of Estradiol Cypionate 10mg/mL due to lack of assurance of sterility. The product was distributed nationwide in the USA and Puerto Rico.
Tailor Made Compounding is recalling 93 vials of Testosterone Enanthate due to lack of assurance of sterility. The affected batches were distributed nationwide and in Puerto Rico.
TMC Acquisition LLC is recalling Testosterone Cypionate injectable vials (100mg/ml) due to lack of assurance of sterility. The recall affects 273 vials distributed nationwide in the USA and Puerto Rico.
A compounded sermorelin/glycine injectable has been recalled because the manufacturer cannot assure the product is sterile. The recall affects approximately 2,870 vials distributed nationwide.
Tailor Made Compounding is recalling 243 vials of Nandrolone Decanoate injectable medication due to lack of sterility assurance. The affected product was distributed nationwide in the USA and Puerto Rico.
Tailor Made Compounding is recalling 1,856 vials of NAD+ 200mg/mL because the company cannot assure the product meets sterility requirements. The affected vials were distributed nationwide to the United States and Puerto Rico.
Tailor Made Compounding is recalling 25 vials of a compounded injectable product due to lack of assurance of sterility. The affected batches were distributed nationwide.
Tailor Made Compounding recalls 101 vials of Glycyrrhizic Acid (8mg/mL) nationwide due to lack of assurance of sterility in this injectable preparation. Patients should contact their healthcare provider.
Methylene Blue Hypotonic Solution vials are being recalled nationwide and in Puerto Rico due to lack of assurance of sterility. Affected vials should not be used.
Tailor Made Compounding is recalling Procaine HCL 2% injectable solution due to lack of sterility assurance. The recall affects 58 vials distributed nationwide.
Tailor Made Compounding is recalling Glutathione 200mg/ml injectable vials due to lack of assurance of sterility. The recall affects 485 vials distributed nationwide in the USA and Puerto Rico.
Tailor Made Compounding is recalling 90 vials of GAC (Glutamine/Arginine/L-Carnitine) injectable solution distributed nationwide and in Puerto Rico due to lack of assurance of sterility.
Tailor Made Compounding is recalling PT-141 10mg/mL vials nationwide due to inability to assure sterility. The recall affects 392 vials in 1mL and 2mL sizes distributed in 2022.
Tailor Made Compounding is recalling 5,842 vials of compounded semaglutide/cyanocobalamin injectable due to lack of sterility assurance. The product was distributed nationwide in the United States and Puerto Rico.
Tailor Made Compounding is recalling 176 vials of testosterone cypionate/propionate injectable due to lack of assurance of sterility. The product was distributed nationwide.
Tailor Made Compounding is recalling 246 vials of compounded testosterone injections distributed nationwide due to lack of assurance of sterility. Non-sterile injectable medications may pose a risk of infection.
Tailor Made Compounding is recalling 924 vials of Methionine/Inositol/Choline B12 + Carnitine injectable compound nationwide due to lack of assurance of sterility.
Tailor Made Compounding is recalling 1,562 vials of Sermorelin/Glycine injectable distributed nationwide because the manufacturer cannot assure the product meets sterility standards. Patients should stop using the recalled product and contact their healthcare provider.
Tailor Made Compounding recalls Glutathione 200mg/mL injectable vials due to lack of sterility assurance. The FDA Class II recall affects 40 vials distributed nationwide.
Tailor Made Compounding is recalling Levocarnitine 500mg/mL vials nationwide due to lack of sterility assurance, a Class II FDA recall.
TMC Acquisition LLC is recalling Folic Acid 5mg/mL injectable vials due to lack of assurance of sterility. The recall affects 45 units distributed nationwide and in Puerto Rico.
Tailor Made Compounding is recalling 60 GOAL injectable vials nationwide due to lack of sterility assurance, which may pose a contamination risk.
TMC Acquisition LLC is recalling Alpha Lipoic Acid 25mg/mL vials due to lack of assurance of sterility in manufacturing. The product was distributed nationwide.
Tailor Made Compounding recalls 39 vials of a compounded injectable product for lack of assurance of sterility. Distribution was nationwide in the USA and Puerto Rico.