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 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 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 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 Vitamin B-Complex injectable vials (10 mL and 30 mL) distributed nationwide USA and Puerto Rico due to lack of assurance of sterility.
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.
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.
Tailor Made Compounding recalls 41 vials of Testosterone Cypionate/Anastrozole due to lack of assured sterility. FDA Class II recall affects products distributed nationwide.
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.
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 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.
TMC Acquisition LLC is recalling testosterone injectable products (58 vials) distributed nationwide and to Puerto Rico due to lack of assurance of sterility in manufacturing.
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.
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 25 vials of a compounded injectable product due to lack of assurance of sterility. The affected batches were distributed nationwide.
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 93 vials of Testosterone Enanthate due to lack of assurance of sterility. The affected batches were distributed nationwide and in 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 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 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 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 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.
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.
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 is recalling 60 GOAL injectable vials nationwide due to lack of sterility assurance, which may pose a contamination risk.