Drug Recall Enforcement Report Class III voluntary initiated by Grato Holdings, Inc., originally initiated on 10-30-2023 for the product V-FORCE Homeopathic, 1 FL OZ (30 ml) per glass bottle, Distributed by: BioActive Nutritional, Inc., 1803 N. Wickham Rd., Melbourne, FL 32935 The product was recalled due to incorrect product formulation: product contains active ingredient glandula suprarenalis suis 8x instead of glandula suprarenalis bovine 8x (as stated on the product label).. The product was distributed in Distributed To One Direct Account In Florida With Possible Further Distribution Out Of State. and the recall is currently completed.
| Field Name |
Field Value |
| Event ID |
93354 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). |
| Recall Number |
D-0099-2024 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). |
| Recall Classification |
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences. 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 |
Distributed to one direct account in Florida with possible further distribution out of state. 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 |
V-FORCE Homeopathic, 1 FL OZ (30 ml) per glass bottle, Distributed by: BioActive Nutritional, Inc., 1803 N. Wickham Rd., Melbourne, FL 32935 |
| Reason For Recall |
Incorrect Product Formulation: product contains Active Ingredient Glandula Suprarenalis Suis 8X instead of Glandula Suprarenalis Bovine 8X (as stated on the product label). What is the Reason for Recall?
Information describing how the product is defective. |
| Product Quantity |
1,333 30mL bottles 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 |
11-15-2023 |
| Recall Initiation Date |
10-30-2023 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 |
Telephone 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 |
Grato Holdings, Inc. |
| Code Info |
Lot: Z65842 no exp date on product 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. |