FDA Recall D-0944-2023

New Vitalis Pharmacy LLC dba New Vitalis Pharmacy · Louisville, KY

Class II Ongoing 1036 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

Product

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

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

Quantity: 102 vials

Reason for recall

Lack of Assurance of Sterility

Recall record

Recall number: D-0944-2023
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: E-Mail
Distribution: Nationwide
Recall initiated: 2023-07-13
Classified by FDA Center: 2023-07-24
FDA published: 2023-08-02
Recalling firm: New Vitalis Pharmacy LLC dba New Vitalis Pharmacy
Firm location: Louisville, KY

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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