Drug recall: Semaglutide/Cyanocobalamin 2mg/0.4mg/mL, 1mLvials, Tailor Made Compounding.
FDA enforcement event 92896 is a drug recall by TMC Acquisitions LLC dba Tailor Made Compounding of Nicholasville, KY, initiated 15 Aug 2023 and classified Class II, with 2 product records.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 59% of the 281 drug enforcement events initiated in 2023 carry the same class.
Status: Terminated, terminated 30 Sep 2024. Initiation: voluntary: firm initiated. This is the only enforcement event on this register for TMC Acquisitions LLC dba Tailor Made Compounding.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
TMC Acquisitions LLC dba Tailor Made Compounding, Nicholasville, KY.
Reason for recall
"Lack of Assurance of Sterility"
Distribution
"Nationwide within the USA"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-1105-2023 | Semaglutide/Cyanocobalamin 2mg/0.4mg/mL, 1mLvials, Tailor Made Compounding. | 9 vials | Class II | Terminated | 30 Aug 2023 |
| D-1106-2023 | NAD+ 200mg/ml, 10ml vials, Tailor Made Compounding. | 99 vials | Class II | Terminated | 30 Aug 2023 |
Context
Questions and answers
Why was this drug recalled?
FDA's record gives the reason for recall as: "Lack of Assurance of Sterility"
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Nationwide within the USA"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 30 Sep 2024. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.