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 180 vials of BCAA (branched-chain amino acid) injections nationwide due to inability to assure the product maintained sterility. Affected batches expire between April and June 2022.
Tailor Made Compounding is recalling Biotin 5mg/mL injections distributed nationwide and in Puerto Rico because the manufacturer cannot assure the products were sterilized according to FDA standards.
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.
Testosterone propionate injectable vials are being recalled due to lack of assurance of sterility. The recall affects product distributed nationwide in the USA and Puerto Rico.
Tailor Made Compounding is recalling 414 vials of Testosterone Enanthate 200mg/ml (5 mL and 10 mL) due to lack of assurance of sterility. The product was distributed nationwide in the USA and Puerto Rico.
Tailor Made Compounding is recalling 232 vials of Methionine/Inositol/Choline B12 injectable across the U.S. and Puerto Rico due to lack of assurance of sterility. Patients who received this medication should contact their healthcare provider.
TMC Acquisition LLC is recalling specific batches of Hydroxocobalamin Preservative Free injectable due to lack of sterility assurance. The affected vials were distributed nationwide in the USA and Puerto Rico.
Tailor Made Compounding recalls 41 vials of Testosterone Cypionate/Anastrozole due to lack of assured sterility. FDA Class II recall affects products distributed nationwide.
TMC Acquisition LLC is recalling Calcium Chloride Preservative Free injectable solution in 5 mL and 30 mL vials due to lack of assurance of sterility. The recall affects 138 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 19 vials of Dexpanthenol 250mg/mL due to lack of assurance of sterility. Two batches with different expiration dates were distributed nationwide in the USA and Puerto Rico.
Tailor Made Compounding is recalling 1,208 vials of Sermorelin due to inability to assure sterility. The product was distributed nationwide in the USA and Puerto Rico across multiple batch lots.
Tailor Made Compounding is recalling Vitamin B-Complex injectable vials (10 mL and 30 mL) distributed nationwide USA and Puerto Rico due to lack of assurance of sterility.
Tailor Made Compounding is recalling Vitamin B-Complex Preservative Free injectable vials (batch 03112233B) nationwide due to lack of assurance of sterility. The product should not be used.
Tailor Made Compounding recalled 9,993 vials of compounded semaglutide/cyanocobalamin due to lack of assurance of sterility. No illnesses have been reported.
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 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 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 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 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 Methylcobalamin Preservative Free 10mg/mL injectable due to lack of assurance of sterility. The affected batch may not meet sterility standards required for injectable medications.
Tailor Made Compounding is recalling 106 vials of compounded testosterone/anastrozole injectable due to lack of sterility assurance. The product was distributed nationwide in the USA and Puerto Rico.
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 recalls Testosterone Cypionate injections due to lack of sterility assurance. The recall affects 4,219 vials distributed nationwide.
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.