Reumo Flex caplets, packaged in 30-count boxes, Manufactured by: Grupo Yepenza de Mexico, SA de CV, Comerciantes 5824 Co
Summary
The FDA issued a Class I for Reumo Flex caplets, packaged in 30-count boxes, Manufactured by: Grupo Yepenza d by Botanical Be. Reason: Marketed Without an Approved NDA/ANDA: products found to contain undeclared diclofenac..
Details
Source
Drug Recall
External ID
D-0225-2024
Action Date
2023-12-06
Status
Ongoing
Category
drug
Product Description
Reumo Flex caplets, packaged in 30-count boxes, Manufactured by: Grupo Yepenza de Mexico, SA de CV, Comerciantes 5824 Col Arcos de Guadalupe, Zapopan Jal Mexico, UPC 7 502214 014598
Lot/Code Info: All lots, exp 10/20/2024
Reason for Recall
Marketed Without an Approved NDA/ANDA: products found to contain undeclared diclofenac.
Distribution
USA Nationwide
Type: Voluntary: Firm initiated
Recall Initiated: 2023-10-20
Company
El Paso, TX
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 46 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Botanical Be has 3 FDA actions in our database, including 3 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 (Botanical Be) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Botanical Be have FDA actions?
Botanical Be has 3 FDA actions in our database, including 3 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0225-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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