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Recall Observatory FDA recall evidence

Drug product

Thiamine HCl/Pyridoxine HCl 20 mg/mL /100mg/ml Injection Solution, 30mL Amber Glass Vial, Rx only, AnazaoHealth, 7465 W. Sunset Road, Las Vegas, NV, NDC 72682-8721-3.

D-0204-2024

November 22, 2023

Class II

Product summary

Firm
AnazaoHealth Corporation
Event
Event 93500
Status
Terminated
Classification
Class II
Quantity
3,363 vials
Official record key
drug-enforcement:D-0204-2024

Official wording

Reason: Presence of Particulate Matter.

Code information: Lots: 508029, Exp: 12/14/23; 513191, Exp: 12/22/23; 524670, Exp: 01/12/24; 526254, Exp: 01/13/24; 530738, Exp: 01/19/23; 533570, Exp: 01/25/24; 538736, Exp: 02/03/24; 543220, Exp:02/16/24; 543508, Exp: 02/17/24; 545675, Exp: 02/22/24

Distribution pattern: Nationwide in the USA.

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    Particulate Matter