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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

AnazaoHealth B-Complex and Thiamine/Pyridoxine Injections Recalled

Agency Publication Date: December 26, 2023
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Summary

AnazaoHealth Corporation is recalling 9,070 vials of B-Complex and Thiamine/Pyridoxine injection solutions due to the presence of particulate matter. The recall includes B-Complex (thiamine, riboflavin, niacinamide, dexpanthenol, pyridoxine) and Thiamine HCl/Pyridoxine HCl sterile injection vials. These prescription medications were distributed nationwide across the United States to healthcare providers and pharmacies. To date, no injuries or adverse events have been reported related to this issue.

Risk

The presence of particulate matter in a sterile injectable drug poses a significant health risk. If injected, these particles can cause local inflammation, allergic reactions, or travel through the bloodstream to cause embolisms (blockages) in the heart, lungs, or brain, which can lead to organ damage or life-threatening complications.

What You Should Do

  1. This recall affects AnazaoHealth B-Complex (74/2/75/2/2 MG/ML) and Thiamine HCl/Pyridoxine HCl (20 mg/mL /100mg/ml) injection solutions sold in 30mL sterile vials.
  2. Check the vial label for NDC codes 72682-2230-3 or 72682-8721-3 and the specific lot number and expiration date. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled product immediately and do not administer it to patients.
  4. Contact AnazaoHealth Corporation or your distributor to arrange for the return of any remaining affected vials.
  5. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.

Affected Products

Product: B-Complex (Thiamine HCI / Riboflavin / Niacinamide / Dexpanthenol / Pyridoxine HCI) Injection (30mL)
Variants: 74/2/75/2/2 MG/ML, 30ML Sterile Multiple-Dose Vial
Lot Numbers:
505075 (Exp: 02/05/24)
505596 (Exp: 02/06/24)
506155 (Exp: 02/07/24)
508103 (Exp: 02/13/24)
510837 (Exp: 02/19/24)
512411 (Exp: 02/20/24)
514856 (Exp: 02/25/24)
515642 (Exp: 02/28/24)
518309 (Exp: 03/05/24)
524262 (Exp: 03/12/24)
524266 (Exp: 03/12/24)
524909 (Exp: 03/13/24)
526526 (Exp: 03/16/24)
529204 (Exp: 03/18/24)
530858 (Exp: 03/20/24)
535766 (Exp: 03/30/24)
NDC:
72682-2230-3

Rx only product manufactured in Las Vegas, NV.

Product: Thiamine HCl/Pyridoxine HCl Injection Solution (30mL)
Variants: 20 mg/mL /100mg/ml, 30mL Amber Glass Vial
Lot Numbers:
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)
NDC:
72682-8721-3

Rx only product manufactured in Las Vegas, NV.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93500
Status: Resolved
Manufacturer: AnazaoHealth Corporation
Sold By: AnazaoHealth Corporation; Healthcare providers; Pharmacies
Manufactured In: United States
Units Affected: 2 products (5,707 vials; 3,363 vials)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.