Why it was recalled
Marketed Without an Approved NDA/ANDA: products found to contain undeclared diclofenac.
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 numbers, UPCs & expiration codes
All lots, exp 10/20/2024
Where it was sold
USA Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0225-2024
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- Oct 20, 2023
- FDA report date
- Dec 6, 2023
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Botanical Be
Original FDA data
Every field from FDA enforcement report D-0225-2024, exactly as published.
Show all FDA fields
- City
- El Paso
- State
- TX
- Status
- Ongoing
- Country
- United States
- Event ID
- 93257
- Address
- 360 Jardin Bello
- Code information
- All lots, exp 10/20/2024
- Postal code
- 79932-2357
- Report date
- Dec 6, 2023
- Product type
- Drugs
- Recall number
- D-0225-2024
- Classification
- Class I
- Recalling firm
- Botanical Be
- Reason for recall
- Marketed Without an Approved NDA/ANDA: products found to contain undeclared diclofenac.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- USA Nationwide
- Recall initiation date
- Oct 20, 2023
- Initial firm notification
- Telephone
- Center classification date
- Jan 12, 2024