Food, drugs, devices › New Vitalis Pharmacy LLC dba New Vitalis Pharmacy
Drug recall: Testosterone Cypionate-Testosterone Propionate 180-20 mg/mL in cottonseed oil, Compounded Rx, For Intramuscular Use Only
New Vitalis Pharmacy LLC dba New Vitalis Pharmacy (Louisville, KY) initiated this drug recall on 13 Jul 2023; FDA lists 1 product record under event 92699, classified Class II.
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: Ongoing. Initiation: voluntary: firm initiated. New Vitalis Pharmacy LLC dba New Vitalis Pharmacy has 3 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
New Vitalis Pharmacy LLC dba New Vitalis Pharmacy, Louisville, KY.
Reason for recall
"Lack of Assurance of Sterility"
Distribution
"Nationwide"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-0944-2023 | Testosterone Cypionate-Testosterone Propionate 180-20 mg/mL in cottonseed oil, Compounded Rx, For Intramuscular Use Only, a) 1 mL, b) 5 mL Multi-Dose Vial, New Vitalis Pharmacy, 4139 Cadillac Ct, Ste 201, Louisville, KY 40213 | 102 vials | Class II | Ongoing | 2 Aug 2023 |
Context
Other enforcement events for New Vitalis Pharmacy LLC dba New Vitalis Pharmacy
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 22 Sep 2021 | Testosterone Cypionate Testosterone Propionate, 180mg/mL, 20mg/mL, 1 mL vial, Rx only, New Vitalis Pharmacy 4139 Cadilla | Drug | Class II | 1 |
| 1 Oct 2019 | Testosterone Cypionate 180 mg/mL/Testosterone Propionate 20mg/mL Oil Injection Solution, 10 mL per vial, New Vitalis Pha | Drug | Class II | 1 |
All 3 events for New Vitalis Pharmacy LLC dba New Vitalis Pharmacy
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"
Is the recall still ongoing?
FDA lists the status as Ongoing. "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.