FDA recall D-0558-2024

MexHealth LLC · Class II · drug

Product

OSSOS-SANS Reforzado con: Glucosamina Curcuma Ortiga tablets, packaged in a 30-count bottle, DISTRIBUIDOR POR: Naturistas Especializados, Alce Blanco 180-A Fracc. Industrial, Edo. de Mexico C.P. 53370

Reason for recall

Marketed Without An Approved NDA/ANDA: FDA laboratory analysis found the product to contain undeclared diclofenac and methocarbamol,

Distribution

US Nationwide

Key facts

Status
Ongoing
Initiation date
2024-05-22
Report date
2024-06-26
Voluntary/Mandated
Voluntary: Firm initiated
Location
La Mesa, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0558-2024