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Recall Observatory FDA recall evidence

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

D-0558-2024

May 22, 2024

Class II

Product summary

Firm
MexHealth LLC
Event
Event 94714
Status
Ongoing
Classification
Class II
Quantity
20 bottles
Official record key
drug-enforcement:D-0558-2024

Official wording

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

Code information: Lot Number: H29585, No Expiration date

Distribution pattern: US Nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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