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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

8046255 Canada Inc. DBA Viatrexx: Various Viatrexx Sterile Vials Recalled for Lack of Assurance of Sterility

Agency Publication Date: November 14, 2019
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Summary

Approximately 397 units of 23 different Viatrexx sterile multi-dose medication vials are being recalled because they were manufactured in a way that cannot guarantee they are sterile. These products, which include varieties like Viatrexx-Connectissue, Viatrexx-MuSkel-Neural, and Viatrexx-Infla, are prescription-only (Rx) and were distributed to physicians for use. Using a medication that is not sterile can lead to serious, potentially life-threatening infections, especially when the product is administered via injection.

Risk

The manufacturing process failed to provide required assurance of sterility, meaning the vials may contain bacteria, fungi, or other contaminants. If these non-sterile products are injected or administered to patients, they can cause localized or systemic infections that may require medical intervention or hospitalization.

What You Should Do

  1. Check your medical supplies for any Viatrexx 10 mL multi-dose vials with 'Lot Numbers' starting with '19-S' and an expiration date of 'May: 2020'. Specific products include Connectissue (Lot 19-S00001), MuSkel-Neural (Lot 19-S00002), Ouch (Lot 19-S00003), and Infla (Lot 19-S00012).
  2. Immediately stop using any affected vials and quarantine the remaining stock to prevent further administration to patients.
  3. Contact your healthcare provider or pharmacist if you have received any of these products and are concerned about your health or have experienced symptoms of infection.
  4. Return any unused vials to your pharmacy or the place of purchase for a refund and contact Viatrexx Bio Incorporated for further instructions regarding the return process.
  5. For additional questions or to report a complaint, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

๐Ÿ’ฐFull Refund

Contact healthcare provider and return product

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Viatrexx-Connectissue (10 mL)
Model:
Item: VSPC0090
NDC 73069-100-41
Recall #: D-0326-2020
Lot Numbers:
19-S00001 (Exp. May: 2020)
Date Ranges: Expiration May 2020
Product: Viatrexx-MuSkel-Neural (10 mL)
Model:
Item: VSPC4020
NDC 73069-347-41
Recall #: D-0327-2020
Lot Numbers:
19-S00002 (Exp. May: 2020)
Date Ranges: Expiration May 2020
Product: Viatrexx-Ouch (10 mL)
Model:
Item: VSPC0500
NDC 73069-402-41
Recall #: D-0328-2020
Lot Numbers:
19-S00003 (Exp. May: 2020)
Date Ranges: Expiration May 2020
Product: Viatrexx-Ithurts (10 mL)
Model:
Item: VSPC0290
NDC 73069-270-41
Recall #: D-0329-2020
Lot Numbers:
19-S00004 (Exp. May: 2020)
Date Ranges: Expiration May 2020
Product: Viatrexx-Adipose (10 mL)
Model:
Item: VSPC0008
NDC 73069-024-41
Recall #: D-0330-2020
Lot Numbers:
19-S00005 (Exp. May: 2020)
Date Ranges: Expiration May 2020
Product: Viatrexx-Systemic Detox (10 mL)
Model:
Item: VSPC0665
NDC 73069-500-41
Recall #: D-0331-2020
Lot Numbers:
19-S00007 (Exp. May: 2020)
Date Ranges: Expiration May 2020
Product: Viatrexx-Articula (10 mL)
Model:
Item: VSPC0031
NDC 73069-037-41
Recall #: D-0332-2020
Lot Numbers:
19-S00008 (Exp. May: 2020)
Date Ranges: Expiration May 2020
Product: Viatrexx-Neuro 3 (10 mL)
Model:
Item: VSPC0463
NDC 73069-373-41
Recall #: D-0333-2020
Lot Numbers:
19-S00010 (Exp. May: 2020)
Date Ranges: Expiration May 2020
Product: Viatrexx-Infla (10 mL)
Model:
Item: VSPC0279
NDC 73069-249-41
Recall #: D-0334-2020
Lot Numbers:
19-S00012 (Exp. May: 2020)
Date Ranges: Expiration May 2020
Product: Viatrexx-Collagen (10 mL)
Model:
Item: VSPC0085
NDC 73069-095-41
Recall #: D-0335-2020
Lot Numbers:
19-S00014 (Exp. May: 2020)
Date Ranges: Expiration May 2020
Product: Viatrexx-Prolo (10 mL)
Model:
Item: VSPC0558
NDC 73069-443-41
Recall #: D-0336-2020
Lot Numbers:
19-S00016 (Exp. May: 2020)
Date Ranges: Expiration May 2020
Product: Viatrexx-Lymph 1 (10 mL)
Model:
Item: VSPC0370
NDC 73069-310-41
Recall #: D-0337-2020
Lot Numbers:
19-S00017 (Exp. May: 2020)
Date Ranges: Expiration May 2020
Product: Viatrexx-Mesenchyme (10 mL)
Model:
Item: VSPC0092
NDC 73069-102-41
Recall #: D-0338-2020
Lot Numbers:
19-S00018 (Exp. May: 2020)
Date Ranges: Expiration May 2020
Product: Viatrexx-GI (10 mL)
Model:
Item: VSPC0211
NDC 73069-189-41
Recall #: D-0339-2020
Lot Numbers:
19-S00019 (Exp. May: 2020)
Date Ranges: Expiration May 2020
Product: Viatrexx-Arthros (10 mL)
Model:
Item: VSPC0030
NDC 73069-035-41
Recall #: D-0340-2020
Lot Numbers:
19-S00021 (Exp. May: 2020)
Date Ranges: Expiration May 2020
Product: Viatrexx-Immunexx (10 mL)
Model:
Item: VSPC0270
NDC 73069-244-41
Recall #: D-0341-2020
Lot Numbers:
19-S00023 (Exp. May: 2020)
Date Ranges: Expiration May 2020
Product: Viatrexx-Relief + (10 mL)
Model:
Item: VSPC0615
NDC 73069-450-41
Recall #: D-0342-2020
Lot Numbers:
19-S00024 (Exp. May: 2020)
Date Ranges: Expiration May 2020
Product: Viatrexx-Intra-Cell (10 mL)
Model:
Item: VSPC0280
NDC 73069-250-41
Recall #: D-0343-2020
Lot Numbers:
19-S00025 (Exp. May: 2020)
Date Ranges: Expiration May 2020
Product: Viatrexx-Facial (10 mL)
Model:
Item: VSPC0184
NDC 73069-164-41
Recall #: D-0344-2020
Lot Numbers:
19-S00026 (Exp. May: 2020)
Date Ranges: Expiration May 2020
Product: Viatrexx-Hair (10 mL)
Model:
Item: VSPC0251
NDC 73069-206-41
Recall #: D-0345-2020
Lot Numbers:
19-S00009 (Exp. May: 2020)
Date Ranges: Expiration May 2020
Product: Viatrexx-Neuro (10 mL)
Model:
Item: VSPC0460
NDC 73069-375-41
Recall #: D-0346-2020
Lot Numbers:
19-S00020 (Exp. May: 2020)
Date Ranges: Expiration May 2020
Product: Viatrexx-Male+ (10 mL)
Model:
Item: VSPC0400
NDC 73069-320-41
Recall #: D-0347-2020
Lot Numbers:
19-S00022 (Exp. May: 2020)
Date Ranges: Expiration May 2020
Product: Viatrexx-ANS/CNS (10 mL)
Model:
Item: VSPC0025
NDC 73069-039-41
Recall #: D-0348-2020
Lot Numbers:
19-S00027 (Exp. May: 2020)
Date Ranges: Expiration May 2020

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 84055
Status: Resolved
Manufacturer: 8046255 Canada Inc. DBA Viatrexx
Sold By: Physicians
Manufactured In: Canada
Units Affected: 23 products (24 vials; 61 vials; 19 vials; 12 vials; 4 vials; 5 vials; 69 vials; 7 vials; 54 vials; 22 vials; 42 vials; 3 vials; 7 vials; 3 vials; 6 vials; 18 vials; 1 vial; 8 vials; 13 vials; 3 vials; 13 vials; 2 vials; 1 vial)
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.

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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.