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 recalls 39 vials of a compounded injectable product for lack of assurance of sterility. Distribution was nationwide in the USA and Puerto Rico.
Tailor Made Compounding recalls 84 vials of Dexpanthenol Preservative Free due to lack of assurance of sterility. The medication was distributed nationwide and in Puerto Rico.
Tailor Made Compounding is recalling 63 vials of Hydroxocobalamin 25mg/mL injectable solution nationwide due to lack of assurance of sterility. Consumers should not use affected batches.
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.
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 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 220 vials of Pentosan Polysulfate Sodium due to lack of assurance of sterility. The affected batches were distributed nationwide in the United States and Puerto Rico.
Tailor Made Compounding recalled 9,993 vials of compounded semaglutide/cyanocobalamin due to lack of assurance of sterility. No illnesses have been reported.
Tailor Made Compounding recalls two batches of Alprostadil/Papaverine/Phentolamine injectable due to lack of sterility assurance. The recall affects 32 vials distributed nationwide and in Puerto Rico.
Tailor Made Compounding is recalling 924 vials of Methionine/Inositol/Choline B12 + Carnitine injectable compound nationwide due to lack of assurance of sterility.
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.
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 652 vials of Methylcobalamin 10mg/mL injectable due to lack of assurance of sterility. No illnesses or injuries have been reported.
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 recalls Testosterone Cypionate injections due to lack of sterility assurance. The recall affects 4,219 vials distributed nationwide.
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 Glutathione 200mg/mL injectable vials due to lack of sterility assurance. The FDA Class II recall affects 40 vials distributed nationwide.
Tailor Made Compounding has recalled Vitamin D3 50,000IU/mL vials nationwide due to lack of sterility assurance during manufacturing. No illnesses have been reported.
Tailor Made Compounding is recalling Levocarnitine 500mg/mL vials nationwide due to lack of sterility assurance, a Class II FDA recall.
TMC Acquisition LLC recalls 191 vials of Methylcobalamin 1mg/mL distributed nationwide and in Puerto Rico due to lack of sterility assurance. Consult your healthcare provider regarding any vials in your possession.
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 has recalled 182 vials of Melanotan I injectable due to lack of assurance of sterility. The affected vials were distributed nationwide and in Puerto Rico.
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 Teriparatide injectable syringes nationwide due to lack of assurance of sterility. Patients using affected batches should contact their healthcare provider immediately.
Tailor Made Compounding is recalling ascorbic acid injectable vials due to lack of sterility assurance. The affected vials were distributed nationwide and in Puerto Rico.