The Recall Desk

FDA (Drugs) recall action 89909

TMC Acquisition LLC dba Tailor Made Compounding recalled 52 products on 2022-07-20

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.

Products
52
Announced
2022-07-20
Critical
0
Units
35,498

Why these products were recalled

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.

States named across these recalls

51–52 of 52

  • HighFDA (Drugs)··2022-07-20

    Testosterone injectable drug recall due to lack of sterility assurance

    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.

    Product
    Testosterone Cypionate/Enanthate 100/100mg/ml, a) 2 mL-vial, b) 4 mL-vial c) 10 mL-vial, Room temperature, Tailor Made Compounding
    Category
    Distribution
    1 state