Drug Enforcement D-0558-2024

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

Status

Ongoing

Classification

Class II

Report Date

June 26, 2024

Termination Date

—

Product Information

Product description
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
Product quantity
20 bottles
Reason for recall
Marketed Without An Approved NDA/ANDA: FDA laboratory analysis found the product to contain undeclared diclofenac and methocarbamol,
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
US Nationwide

Location & Firm

Recalling firm
MexHealth LLC
Address
4628 Denwood Rd, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0558-2024
Event ID
94714
Recall initiation date
May 22, 2024
Center classification date
June 17, 2024
Code info
Lot Number: H29585, No Expiration date
More code info
—