B-Force, Homeopathic, 1 Fl Oz (30 mL) bottle, Distributed by: BioActive Nutritional, Inc., Melbourne, FL 32935, NDC 4385
Summary
The FDA issued a Class III for B-Force, Homeopathic, 1 Fl Oz (30 mL) bottle, Distributed by: BioActive Nutritio by Grato Holdings, Inc.. Reason: Superpotent.
Details
Source
Drug Recall
External ID
D-0653-2021
Action Date
2021-07-21
Status
Terminated
Category
drug
Product Description
B-Force, Homeopathic, 1 Fl Oz (30 mL) bottle, Distributed by: BioActive Nutritional, Inc., Melbourne, FL 32935, NDC 43857-0576-1
Lot/Code Info: Lot: Z61917
Quantity Affected: 1480 bottles
Reason for Recall
Superpotent
Distribution
FL
Type: Voluntary: Firm initiated
Recall Initiated: 2021-06-18
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 22 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-0653-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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