Artri King Reforzado con Ortiga Omega 3 Tablets, ORIGINAL, 100-count bottles, Melchor Ocampo No. 55 Local D, Delegacion
Summary
The FDA issued a Class I for Artri King Reforzado con Ortiga Omega 3 Tablets, ORIGINAL, 100-count bottles, Me by Walmart Inc. Reason: Marketed Without An Unapproved NDA/ANDA: Product lot found to be tainted with undeclared diclofenac, an FDA approved nonsteroidal anti-inflammatory dr.
Details
Source
Drug Recall
External ID
D-1157-2022
Action Date
2022-06-22
Status
Completed
Category
drug
Product Description
Artri King Reforzado con Ortiga Omega 3 Tablets, ORIGINAL, 100-count bottles, Melchor Ocampo No. 55 Local D, Delegacion Xochimilco, C.P. 16800, Mexico, D.F., UPC 7 501031 111190.
Lot/Code Info: Lot: LTARTKNGOMG30720, Exp Diciembre 2026
Quantity Affected: 1308 bottles total
Reason for Recall
Marketed Without An Unapproved NDA/ANDA: Product lot found to be tainted with undeclared diclofenac, an FDA approved nonsteroidal anti-inflammatory drug (NSAID) for the treatment of pain and inflammation.
Distribution
Nationwide in the USA.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-05-24
Company
Bentonville, AR
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 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 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 (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-1157-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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