← FDA ENFORCEMENT
D-0944-2023Class II

New Vitalis Pharmacy LLC dba New Vitalis Pharmacy

Recalling firm
New Vitalis Pharmacy LLC dba New Vitalis Pharmacy
Product type
Drug
Status
Ongoing
Report date
2023-08-02
Distribution
Nationwide
Firm state
KY
Product quantity
102 vials
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental Monitoring
Reason for recall

Lack of Assurance of Sterility

Product description

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

Code / lot info

Lot #: AL-05222023@901, BUD 7/22/23; AL-06122023@908CS, BUD 8/11/23

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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.