CLASS II Drug recall · Reported 3 Jan 2024 · FDA Enforcement Report
Thiamine HCl/Pyridoxine HCl 20 mg/mL /100mg/ml Injection recalled
AnazaoHealth is recalling Thiamine HCl/Pyridoxine HCl 20 mg/mL /100mg/ml Injection Solution Amber Glass Vial, distributed nationwide in the US. The recall was initiated on 22 Nov 2023 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0204-2024
- FDA event ID
- 93500
- Recalling firm
- AnazaoHealth, Las Vegas, NV
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 22 Nov 2023
- FDA classified
- 26 Dec 2023
- Reported
- 3 Jan 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
- Drug class
- Injectable & IV Drugs
Timeline
| 22 Nov 2023 | Recall initiated by company | |
| 26 Dec 2023 | Classified by FDA | +34 days |
| 3 Jan 2024 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of Particulate Matter.
Product as listed by the FDA
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.
Where it was distributed
Nationwide in the USA.
Questions about this recall
Why was it recalled?
Presence of Particulate Matter.
Which lots are affected?
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 was it sold?
Nationwide in the USA.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 93500| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | B-Complex, Thiamine HCI / Riboflavin / Niacinamide recalled | AnazaoHealth | Particulate Matter | Nationwide |
More recalls from AnazaoHealth
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | B-Complex, Thiamine HCI / Riboflavin / Niacinamide recalled | AnazaoHealth | Particulate Matter | Nationwide |
| Drug | CLASS II | Compounded Plaquex, intravenous injection vial recalled by AnazaoHealth | AnazaoHealth | Manufacturing (CGMP) Deviations | Nationwide |
Other Thiamine recalls
All 14| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | thiamine HCl, 500 mg, 500 mg added recalled | Fresenius Kabi Compounding | Sterility | Nationwide |
| Drug | CLASS II | Thiamine Hydrochloride 3000 mg/ (100mg/mL) recalled | McGuff Compounding Pharmacy Services | Particulate Matter | Nationwide |
| Drug | CLASS II | Thiamine Hydrochloride 200 mg/ (100mg/mL), Riboflavin 2 mg recalled | McGuff Compounding Pharmacy Services | Particulate Matter | Nationwide |
| Drug | CLASS II | Thiamine/ribofla/niacinami/dexpanth/pyridox/hydroxycobal recalled | Pharmacy Innovations | Sterility | Nationwide |
| Drug | CLASS III | Thiamine HCl Injection, USP 200 mg/ (100mg/mL) vials recalledThiamine Hydrochloride | Mylan Institutional | Packaging Defects | Nationwide |