OneMultivitaminic GAF-PLUS Advance 300ml, plastic bottle, Room Temperature
Summary
The FDA issued a Class II for OneMultivitaminic GAF-PLUS Advance 300ml, plastic bottle, Room Temperature by Armonia Natural Store LLC. Reason: Contains undeclared drugs Acetaminophen and Dexamethasone Phosphate, and the undeclared sweetener Aspartame.
Details
Source
Food Recall
External ID
F-0221-2025
Action Date
2024-12-11
Status
Terminated
Category
food
Product Description
OneMultivitaminic GAF-PLUS Advance 300ml, plastic bottle, Room Temperature
Lot/Code Info: Lot# 000297-0060724 Expiration Date:07/2026
Quantity Affected: 64 Bottles
Reason for Recall
Contains undeclared drugs Acetaminophen and Dexamethasone Phosphate, and the undeclared sweetener Aspartame
Distribution
Domestic distribution: FL, GA, NC, SC, RI, NY, NJ, VA, NE, IL, CA, WI
Type: Voluntary: Firm initiated
Recall Initiated: 2024-11-06
Company
Tamarac, FL
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 107 food recalls issued in the same week, part of 204 food-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
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 (Armonia Natural Store LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Armonia Natural Store LLC have FDA actions?
This is the only FDA action we have on record for Armonia Natural Store LLC in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "F-0221-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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