Compounded Testosterone Recalled Over Sterility Concerns

A lack of assurance of sterility has prompted TMC Acquisition, which does business as Tailor Made Compounding, to recall numerous testosterone products, according to the July 20, 2022, US Food and Drug Administration (FDA) Enforcement Report.

The recall affects the following Tailor Made Compounding products, which were distributed throughout the United States and in Puerto Rico:

• testosterone cypionate (GSO), 100 mg/mL, in 1-mL vials from batches 12212109A2 (Exp. 6/19/22) and 01312217A1 (Exp. 7/30/22);
• testosterone cypionate (GSO), 100 mg/mL, in 2-mL vials from batches 10202108A1 (Exp. 4/18/22), 12012125A (Exp. 5/30/22), 02182230A1 (Exp. 8/17/22), and 10202108A1 and 03022222A1 (Exp. 8/29/22);
• testosterone cypionate (GSO), 200 mg/mL, in 2 mL-vials from batches 12212105A2 (Exp. 6/19/22) and 02182229A1 (Exp. 8/17/22);
• testosterone cypionate (GSO), 200 mg/mL, in 4-mL vials from batches 12012121A2 (Exp. 5/30/22), 12212104A2 (Exp. 6/19/22), 01242216A2 (Exp. 7/23/22), and 02182236A1 (Exp. 8/17/22);
• testosterone cypionate (GSO), 200 mg/mL, in 5-mL vials from batches 12072133A1 (Exp. 6/5/22), 01192225A1 (Exp. 7/18/22), and 02182228A1 (Exp. 8/17/22);
• testosterone cypionate (GSO), 200 mg/mL, in 10-mL vials from batches 10142105A (Exp. 4/12/22), 10272105A1 (Exp. 4/25/22), 1102101A1 and 11032120A2 (Exp. 4/30/22), 11222116A2 (Exp. 5/21/22), 12012121A2 (Exp. 5/30/22), 12072132A1 (Exp. 6/5/22), 12152110A1 (Exp. 6/13/22), 12162118A1 (Exp. 6/14/22), 12212103A2 (Exp. 6/19/22), 01052206A1 (Exp. 7/4/22), 01142229A1 (Exp. 7/13/22), 01212207A2 (Exp. 7/20/22), 02042201A1 (Exp. 8/3/22), 02182226A1 (Exp. 8/17/22), and 02252224A1 and 02252226A1 (Exp. 8/24/22);
• testosterone cypionate/anastrozole, 200 mg/0.5 mg/mL, in 10-mL vials from batches 11232117A1 (Exp. 5/22/22) and 01312215A1 (Exp. 7/30/22);
• testosterone cypionate/anastrozole, 200 mg/1 mg/mL, in 4-mL vials from batches 10142123A2 (Exp. 4/12/22) and 02042202A1 (Exp. 8/3/22);
• testosterone cypionate/anastrozole, 200 mg/1 mg/mL, in 10-mL vials from batches 10142121A2 (Exp. 4/12/22), 10202105A1 (Exp. 4/18/22), 11102102A1 (Exp. 4/30/22), and 02042202A1 (Exp. 8/3/22);
• testosterone cypionate/enanthate, 100/100 mg/mL, in 2-mL vials from batch 01142227A1 (Exp. 7/13/22);
• testosterone cypionate/enanthate, 100/100 mg/mL, in 4-mL vials from batches 12012126A2 (Exp. 5/30/22) and 02042203A1 (Exp. 8/3/22);
• testosterone cypionate/enanthate, 100/100 mg/mL, in 10-mL vials from batch 01052207A1 (Exp. 7/4/22);
• testosterone cypionate/enanthate/propionate, 80/80/40 mg, in 5-mL vials from batch 10202107A1 (Exp. 4/18/22);
• testosterone cypionate/enanthate/propionate, 80/80/40 mg, in 10-mL vials from batches 10142120A2 (Exp. 4/12/22), 10272102A1 (Exp. 4/25/22), 11032117A2 and 11102104A2 (Exp. 4/30/22), 01252212A2 (Exp. 7/24/22), and 02182227A1 (Exp. 8/17/22);
• testosterone cypionate/propionate, 180/20 mg/mL, in 5-mL vials from batches 11042102A1 (Exp. 4/30/22), 12072135A1 (Exp. 6/5/22), 01142228A1 (Exp. 7/13/22), and 02182231A1 (Exp. 8/17/22);
• testosterone cypionate/propionate, 180/20 mg/mL, in 10-mL vials from batches 11042102A1 (Exp. 4/30/22) and 01142228A1 (Exp. 7/13/22);
• testosterone enanthate (GSO), 100 mg/mL, in 2-mL vials from batches 11102106A1 (Exp. 4/30/22) and 01142230A1 (Exp. 7/13/22);
• testosterone enanthate (GSO), 200 mg/mL, in 5-mL vials from batches 10142117A2 (Exp. 4/12/22), 10272108A1 (Exp. 4/25/22), 11302113A2 (Exp. 5/29/22), and 02252220A1 (Exp. 8/24/22);
• testosterone enanthate (GSO), 200 mg/mL, in 10-mL vials from batches 10142108A2 (Exp. 4/12/22) and 12072134A1 (Exp. 6/5/22); and
• testosterone propionate, 100 mg/mL, in 10-mL vials from batches 12012123A2 (Exp. 5/30/22) and 01312212A1 (Exp. 7/30/22).

TMC Acquisition voluntarily initiated the recalls March 7, 2022. On July 14, 2022, the FDA designated them Class II. The recall designation signals that use of the product could cause temporary or medically reversible adverse health consequences. A remote possibility of serious harm also exists.