Artri King Reforzado con Ortiga Omega 3 Tablets, ORIGINAL, a) 100-count bottles labeled with UPC 7 501031 111190 and UPC
Summary
The FDA issued a Class II for Artri King Reforzado con Ortiga Omega 3 Tablets, ORIGINAL, a) 100-count bottles by Walmart Inc. Reason: Marketed Without An Unapproved NDA/ANDA: All lots were found to be unapproved drugs based on labeling claims..
Details
Source
Drug Recall
External ID
D-1159-2022
Action Date
2022-06-22
Status
Completed
Category
drug
Product Description
Artri King Reforzado con Ortiga Omega 3 Tablets, ORIGINAL, a) 100-count bottles labeled with UPC 7 501031 111190 and UPC 6 09002 40885, and b) 2 pack of 100-count bottles per carton UPC 3 72426 01434
Lot/Code Info: All product lots.
Quantity Affected: 1308 bottles total
Reason for Recall
Marketed Without An Unapproved NDA/ANDA: All lots were found to be unapproved drugs based on labeling claims.
Distribution
Nationwide in the USA.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-05-24
Company
Bentonville, AR
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 176 drug recalls issued in the same week, part of 272 drug-related FDA actions this month.
Walmart Inc has 7 FDA actions in our database, including 7 recalls.
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 (Walmart Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Walmart Inc have FDA actions?
Walmart Inc has 7 FDA actions in our database, including 7 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-1159-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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