Umary Acido Hialuronico, Suplemento Alimenticio, 850 mg caplets, packaged in 30-count bottles.
Summary
The FDA issued a Class I for Umary Acido Hialuronico, Suplemento Alimenticio, 850 mg caplets, packaged in 30- by MAIN PRODUCTS INC. Reason: Marketed without Approved NDA/ANDA. FDA analysis found product to be tainted with undeclared Diclofenac and Omeprazole..
Details
Source
Drug Recall
External ID
D-0626-2024
Action Date
2024-08-14
Status
Ongoing
Category
drug
Product Description
Umary Acido Hialuronico, Suplemento Alimenticio, 850 mg caplets, packaged in 30-count bottles.
Lot/Code Info: All lots within expiry
Quantity Affected: 57, 340 bottles
Reason for Recall
Marketed without Approved NDA/ANDA. FDA analysis found product to be tainted with undeclared Diclofenac and Omeprazole.
Distribution
Nationwide within the U.S
Type: Voluntary: Firm initiated
Recall Initiated: 2024-07-18
Company
Chula Vista, CA
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 59 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
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 (MAIN PRODUCTS INC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does MAIN PRODUCTS INC have FDA actions?
This is the only FDA action we have on record for MAIN PRODUCTS INC in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0626-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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