Event ID |
88733 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). |
Recall Number |
D-0899-2021 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). |
Recall Classification |
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 What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". |
Distribution Pattern |
Nationwide within the United States What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. |
Product Description |
Testosterone Cypionate Testosterone Propionate, 180mg/mL, 20mg/mL, 1 mL vial, Rx only, New Vitalis Pharmacy 4139 Cadillac Ct # 201 Louisville, KY 40213 |
Reason For Recall |
Lack of Assurance of Sterility What is the Reason for Recall? Information describing how the product is defective. |
Product Quantity |
1,347 vials Product Quantity The amount of product subject to recall. |
Voluntary Mandated |
Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. |
Report Date |
10-06-2021 |
Recall Initiation Date |
09-22-2021 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall. |
Initial Firm Notification |
Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall. |
Product Type |
Drugs |
Recalling Firm |
New Vitalis Pharmacy LLC dba New Vitalis Pharmacy |
Code Info |
Lot, expiry: Lot #AL07202021@901, Exp 9/18/21; Lot #AL07272021@901, Exp 9/25/21; Lot #AL08032021@901, Exp 10/2/21; Lot #AL08102021@901, Exp 10/9/21; Lot #AL08172021@901, Exp 10/16/21; Lot #AL08242021@901, Exp 10/23/21 Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. |
Status |
Completed - A recall which has reached the point at which the firm has actually retrieved and impounded all outstanding product that could reasonably be expected to be recovered, or has completed all product corrections. |