Thiamine HCl/Pyridoxine HCl 20 mg/mL /100mg/ml Injection Solution, 30mL Amber Glass Vial, Rx only...
FDA Recall #D-0204-2024 — Class II — November 22, 2023
Product Description
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.
Reason for Recall
Presence of Particulate Matter.
Recalling Firm
AnazaoHealth Corporation — Las Vegas, NV
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
3,363 vials
Distribution
Nationwide in the USA.
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
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated