OSSOS-SANS Reforzado con: Glucosamina Curcuma Ortiga tablets, packaged in a 30-count bottle, DISTRIBUIDOR POR: Naturista
Summary
The FDA issued a Class II for OSSOS-SANS Reforzado con: Glucosamina Curcuma Ortiga tablets, packaged in a 30-c by MexHealth LLC. Reason: Marketed Without An Approved NDA/ANDA: FDA laboratory analysis found the product to contain undeclared diclofenac and methocarbamol,.
Details
Source
Drug Recall
External ID
D-0558-2024
Action Date
2024-06-26
Status
Ongoing
Category
drug
Product Description
OSSOS-SANS Reforzado con: Glucosamina Curcuma Ortiga tablets, packaged in a 30-count bottle, DISTRIBUIDOR POR: Naturistas Especializados, Alce Blanco 180-A Fracc. Industrial, Edo. de Mexico C.P. 53370
Lot/Code Info: Lot Number: H29585, No Expiration date
Quantity Affected: 20 bottles
Reason for Recall
Marketed Without An Approved NDA/ANDA: FDA laboratory analysis found the product to contain undeclared diclofenac and methocarbamol,
Distribution
US Nationwide
Type: Voluntary: Firm initiated
Recall Initiated: 2024-05-22
Company
La Mesa, CA
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 33 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 (MexHealth LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does MexHealth LLC have FDA actions?
This is the only FDA action we have on record for MexHealth LLC in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0558-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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