Class I · High risk
Kuka Flex Forte caplets
Marketed Without an Approved NDA/ANDA: products found to contain undeclared diclofenac.
Reumo Flex caplets
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
Marketed Without an Approved NDA/ANDA: products found to contain undeclared diclofenac.
Cause type: Chemical / undeclared
A chemical that should not be there - benzene, methanol, lead - or an undeclared prescription drug hidden in a supplement. The label gives no warning: you may be taking a toxic solvent, a heavy metal, or a drug such as sildenafil that interacts with your other medicines. All chemical / undeclared recalls.
What was recalled
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
- Recalling firm
- Botanical Be
- Origin
- TX, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0225-2024 · FDA notice
Treat this as urgent. Class I means FDA judged there is a reasonable probability of serious harm. Find the lot number on your package; if it matches the recalled lots, do not take another dose before you have spoken to your pharmacist or prescriber - today, not next week.
Other recalls by Botanical Be
All 2023 recalls
Class I · High risk
Artri King Reforzado con Origa y Omega 3 tablets
Marketed Without an Approved NDA/ANDA: products found to contain undeclared diclofenac.
Other chemical / undeclared recalls from 2023
All chemical / undeclared recalls
Class I · High risk
Americaine
Chemical Contamination: presence of benzene
Class I · High risk
Magnum XXL 9800
Marketed without an approved NDA/ANDA: Magnum XXL found to contain undeclared active pharmaceutical ingredient (API) - Sildenafil.
Class I · High risk
TING 2% Miconazole Nitrate Athlete's Foot Spray Antifungal Spray Powder
Chemical Contamination; presence of benzene.
Class I · High risk
Dr. Ergin's SugarMD
MARKETED WITHOUT AN APPROVED NDA/ANDA: Product found to be tainted with metformin and glyburide
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