FDA Recalls AnazaoHealth Injectable Vitamin Solution Due to Particulate Matter
AnazaoHealth Corporation is recalling 3,363 vials of Thiamine HCl/Pyridoxine HCl injection solution nationwide due to the presence of particulate matter. Affected lots are identified by lot numbers and expiration dates listed by the FDA.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of an injectable pharmaceutical product with a quality defect (particulate matter). No illnesses or injuries have been reported. Per the rubric, recalls of risk-of-harm products without reported injury are scored at High (3).
Plain-English summary
AnazaoHealth Corporation is recalling Thiamine HCl/Pyridoxine HCl 20 mg/mL/100 mg/mL injection solution (30 mL amber glass vials). The recalled product is a prescription injectable drug distributed nationwide.
The recall was initiated due to the presence of particulate matter in the product. A total of 3,363 vials have been distributed. Ten lots are affected, with expiration dates ranging from December 2023 to February 2024.
Healthcare providers and pharmacists who have received affected lots should stop dispensing the product immediately. Patients currently receiving this medication should consult their healthcare provider about continuation of therapy. The affected lot numbers and expiration dates are available through the FDA.
The recalled product
- 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.
- Manufacturer
- AnazaoHealth Corporation
- Category
- Drug — Injectable Solution
- Hazard
- Affected units
- 3,363
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by AnazaoHealth Corporation under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · AnazaoHealth Corporation
See all →- HighB-Complex Vitamin Injection Vials Recalled for Particulate Matter
FDA (Drugs) · 2024-01-03
- Severe
Same hazard · particulate matter
See all →- ModerateIMAAVY Injection Recalled for Presence of Particulate Matter
FDA (Drugs) · 2026-10-14
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