July 2023 FDA Recall Drug by New Vitalis Pharmacy Llc Dba New Vitalis Pharmacy
D-0944-2023 - Lack of Assurance of Sterility
This Class II drug recall was voluntarily initiated by New Vitalis Pharmacy Llc Dba New Vitalis Pharmacy on July 13, 2023 for the product Drug. The FDA reported the reason for recall as lack of assurance of sterility. The product was distributed Nationwide and the recall is currently ongoing.
Recall Number: D-0944-2023
Lack of Assurance of Sterility
07-13-2023
08-02-2023
102 vials
Recall Profile & Regulatory Data
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
New Vitalis Pharmacy LLC dba New Vitalis Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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
Batch or Lot Expiration Information
Lot# : AL-05222023@901, BUD 7/22/23; AL-06122023@908CS, BUD 8/11/23
