Summary
The FDA issued a Class II for UMARY ACID HYALURONIC, 850 MG CAPLETS, 30-count bottle, UPC7502265120323 by MXBBB. Reason: cGMP Deviations: the firm initiated a recall after notification from the distributor that product may be tainted with undeclared diclofenac and omepra.
Details
Source
Drug Recall
External ID
D-0166-2025
Action Date
2025-01-01
Status
Ongoing
Category
drug
Product Description
UMARY ACID HYALURONIC, 850 MG CAPLETS, 30-count bottle, UPC7502265120323
Lot/Code Info: Lot#: 24183, Exp 07/01/28
Quantity Affected: 321 bottles
Reason for Recall
cGMP Deviations: the firm initiated a recall after notification from the distributor that product may be tainted with undeclared diclofenac and omeprazole, however there is no analytical data confirming that product distributed by the firm is tainted.
Distribution
Product was sold via Amazon Marketplace.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-11-14
Company
El Paso, 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 38 drug recalls issued in the same week, part of 267 drug-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 (MXBBB) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does MXBBB have FDA actions?
This is the only FDA action we have on record for MXBBB in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0166-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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