Summary
The FDA issued a Class II for OZONA ORGANICS LIQUID PROBIOTICS & GO HEALTHY LIQUID PROBIOTICS by Ozona Organics LLC. Reason: Products contain high water activity in the formula that provides a potential for microbial growth..
Details
Source
Food Recall
External ID
F-1616-2023
Action Date
2023-10-04
Status
Terminated
Category
food
Product Description
OZONA ORGANICS LIQUID PROBIOTICS & GO HEALTHY LIQUID PROBIOTICS
Lot/Code Info: Lots #011122, 011228, 020810, 021115, 022023, 030115 and 030301.
Quantity Affected: 24,772 bottles
Reason for Recall
Products contain high water activity in the formula that provides a potential for microbial growth.
Distribution
Nationwide
Type: Voluntary: Firm initiated
Recall Initiated: 2023-07-14
Company
Ozona, TX
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 185 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 (Ozona Organics LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Ozona Organics LLC have FDA actions?
This is the only FDA action we have on record for Ozona Organics LLC in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "F-1616-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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