V-FORCE Homeopathic, 1 FL OZ (30 ml) per glass bottle, Distributed by: BioActive Nutritional, Inc., 1803 N. Wickham Rd.
Summary
The FDA issued a Class III for V-FORCE Homeopathic, 1 FL OZ (30 ml) per glass bottle, Distributed by: BioActiv by Grato Holdings, Inc.. Reason: Incorrect Product Formulation: product contains Active Ingredient Glandula Suprarenalis Suis 8X instead of Glandula Suprarenalis Bovine 8X (as stated .
Details
Source
Drug Recall
External ID
D-0099-2024
Action Date
2023-11-15
Status
Terminated
Category
drug
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
Lot/Code Info: Lot: Z65842 no exp date on product
Quantity Affected: 1,333 30mL bottles
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).
Distribution
Distributed to one direct account in Florida with possible further distribution out of state.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-10-30
Company
Woodbine, IA
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 40 drug recalls issued in the same week, part of 272 drug-related FDA actions this month.
Grato Holdings, Inc. has 7 FDA actions in our database, including 7 recalls.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Grato Holdings, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Grato Holdings, Inc. have FDA actions?
Grato Holdings, Inc. has 7 FDA actions in our database, including 7 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0099-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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