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Class II: temporary or reversible health riskTerminated

AnazaoHealth Thiamine HCl/Pyridoxine HCl 20 mg/mL Recall

Thiamine HCl/Pyridoxine HCl 20 mg/mL /100mg/ml Injection Solution, 30mL Amber Glass Via…

AnazaoHealth Corporation · Las Vegas, NV

Risk level
Class II
Reported by FDA
Jan 3, 2024
Recall ID
D-0204-2024
Check your lot numberHow we source this data

Summary

AnazaoHealth recalled Thiamine HCl/Pyridoxine HCl 20 mg/mL starting Nov 22, 2023. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0204-2024 on Jan 3, 2024. Reason: Presence of Particulate Matter. Status: Terminated.

Why it was recalled

Presence of Particulate Matter.

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.

Lot numbers, UPCs & expiration codes

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

Where it was sold

Nationwide in the USA.

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0204-2024
Classification
Class II
Status
Terminated
Recall initiated
Nov 22, 2023
FDA report date
Jan 3, 2024
Quantity
3,363 vials
Recall type
Voluntary: Firm initiated
Recalling firm
AnazaoHealth Corporation

Original FDA data

Every field from FDA enforcement report D-0204-2024, exactly as published.

Show all FDA fields
City
Las Vegas
State
NV
Status
Terminated
Country
United States
Event ID
93500
Address
7465 W Sunset Rd Ste 1200
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
Postal code
89113-1944
Report date
Jan 3, 2024
Product type
Drugs
Recall number
D-0204-2024
Classification
Class II
Recalling firm
AnazaoHealth Corporation
Product quantity
3,363 vials
Termination date
Sep 29, 2025
Reason for recall
Presence of Particulate Matter.
Voluntary / mandated
Voluntary: Firm initiated
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.
Distribution pattern
Nationwide in the USA.
Recall initiation date
Nov 22, 2023
Initial firm notification
Letter
Center classification date
Dec 26, 2023

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0204-2024, published Jan 3, 2024. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

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