FDA Drug Recalls

Recalls / Class II

Class IID-1194-2022

Product

Anastrozole/Testosterone Cypionate/Propionate 1mg/160mg/40mg/mL, 10 mL-vial, Room Temperature, Tailor Made Compounding

Affected lot / code info
Batch #: 10182113A1, Exp 4/16/2022.

Why it was recalled

Lack of Assurance of Sterility

Recalling firm

Firm
TMC Acquisition LLC dba Tailor Made Compounding
Notification channel
Letter
Type
Voluntary: Firm initiated
Address
200 Moore Dr, Nicholasville, Kentucky 40356-8512

Distribution

Quantity
39
Distribution pattern
Nationwide USA and Puerto Rico

Timeline

Recall initiated
2022-03-07
FDA classified
2022-07-14
Posted by FDA
2022-07-20
Status
Ongoing

Source: openFDA Drug Enforcement endpoint. Recall record D-1194-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.