October 2019 FDA Recall Drug by New Vitalis Pharmacy Llc Dba New Vitalis Pharmacy
D-0523-2020 - Lack of sterility assurance.

This Class II drug recall was voluntarily initiated by New Vitalis Pharmacy Llc Dba New Vitalis Pharmacy on October 1, 2019 for the product Drug. The FDA reported the reason for recall as lack of sterility assurance.. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0523-2020

Reason for Recall
Lack of sterility assurance.
Initiated
10-01-2019
Reported
12-04-2019
Quantity
2981.62 mL

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84189
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Terminated
Recalling Firm About Recalling Firm
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.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distributed Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-09-2023
Product Description About Product Description
Full technical description of the product.
Testosterone Cypionate 180 mg/mL/Testosterone Propionate 20mg/mL Oil Injection Solution, 10 mL per vial, New Vitalis Pharmacy

Batch or Lot Expiration Information

Lot# Lot, expiry: AL-07232019@99, exp 9-23-2019; AL-07312019@99, exp 9-30-2019; AL-08132019@99, exp 10-13-2019; AL-08272019@901, exp 10-27-2019; AL-08282019@909, exp 10-28-2019; Al-09032019@903, exp 11-3-2019