Tailor Made Compounding recall from 2022 remains open on the enforcement file

The Class II recall covers 9,993 vials distributed nationwide and in Puerto Rico, and is still recorded with the status ongoing.

Silver Spring, Maryland, 20 July 2022 — The Food and Drug Administration enforcement file records a Class II recall initiated by TMC Acquisition LLC, trading as Tailor Made Compounding, of Nicholasville, Kentucky, on 7 March 2022 and classified on 14 July 2022. The record covers 9,993 vials of a compounded semaglutide and cyanocobalamin product distributed nationwide and in Puerto Rico, gives the reason as lack of assurance of sterility, and carries the status ongoing.

Source documents

Semaglutide/Cyanocobalamin 5mg/0.2mg/ml, 2ml-vial, Refrigerate, Tailor Made Compounding Enforcement report, Class II · U.S. Food and Drug Administration · 20 July 2022
Identifier
Recall number D-1225-2022
As the record states
Lack of Assurance of Sterility
Recalling firm
TMC Acquisition LLC dba Tailor Made Compounding
Firm location
Nicholasville, KY, United States
Classification
Class II
Status on the record
Ongoing
Quantity
9,993 vials
Distribution
Nationwide USA and Puerto Rico
Initiated
2022-03-07
Classified
2022-07-14