October 2023 FDA Recall Drug by Grato Holdings, Inc.
D-0099-2024 - Incorrect Product Formulation

This Class III drug recall was voluntarily initiated by Grato Holdings, Inc. on October 30, 2023 for the product Drug. The FDA reported the reason for recall as incorrect product formulation. The product was distributed in Distributed to one direct account in Florida with possible further distribution out of state. and the recall is currently terminated.

Recall Number: D-0099-2024

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).
Initiated
10-30-2023
Reported
11-15-2023
Quantity
1,333 30mL bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
93354
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Grato Holdings, Inc.
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.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distributed to one direct account in Florida with possible further distribution out of state.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-12-2024
Product Description About Product Description
Full technical description of 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

Batch or Lot Expiration Information

Lot# Lot: Z65842 no exp date on product