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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

Integrated Health Concepts Inc. dba Conversio Health: Inhalation Medications Recalled Due to Lack of Processing Controls

Agency Publication Date: November 19, 2019
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Summary

Integrated Health Concepts (dba Conversio Health) is voluntarily recalling multiple inhalation medications, including various combinations of Albuterol, Budesonide, Ipratropium, Formoterol, and Triamcinolone. This recall affects all lots of ten different compounded respiratory treatments due to a lack of necessary processing controls during manufacturing. Consumers using these medications for respiratory conditions should contact their healthcare provider or pharmacist immediately, as the safety and quality of the products cannot be guaranteed. These medications were distributed nationwide across the United States.

Risk

The lack of adequate processing controls means the manufacturing environment or methods may not have met safety standards, potentially leading to products that are not sterile or contain incorrect drug levels. Using compromised inhalation medications can lead to ineffective treatment or serious respiratory infections, especially in patients with existing lung conditions.

What You Should Do

  1. Check your medication vials and packaging for the 'Conversio Health' brand name and the San Luis Obispo, CA 93401 address to see if your product is affected.
  2. Identify if you have any of the following medications: Formoterol/Budesonide (3.5ML), Budesonide (3ML), Albuterol/Ipratropium (2ML or 3ML), Albuterol/Ipratropium/Budesonide (3ML), Albuterol/Budesonide (3ML), Albuterol/Ipratropium/Budesonide (3ML), or Albuterol/Ipratropium/Triamcinolone (3ML).
  3. Verify if your medication matches any of these recall numbers: D-0507-2020 through D-0516-2020; note that 'All Lots' of these specific products are included in the recall.
  4. Immediately contact your healthcare provider or pharmacist for guidance on alternative treatments and to report your possession of these recalled items.
  5. Return any unused vials to your pharmacy for a refund and to ensure the products are disposed of safely.
  6. Contact Conversio Health directly at their San Luis Obispo location for further instructions regarding this voluntary recall.
  7. For additional questions or to report a problem, 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

Drug recall baseline remedy

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

Affected Products

Product: Formoterol 12mcg / Budesonide 0.5mg (3.5ML Vial)
Model:
Recall #: D-0507-2020
Lot Numbers:
All Lots
Product: Budesonide 0.4mg (3ML Vial)
Model:
Recall #: D-0508-2020
Lot Numbers:
All Lots
Product: Albuterol 3.75mg / Ipratropium 0.75mg (3ML Vial)
Model:
Recall #: D-0509-2020
Lot Numbers:
All Lots
Product: Albuterol 2.5mg / Ipratropium 0.75mg (2ML Vial)
Model:
Recall #: D-0510-2020
Lot Numbers:
All Lots
Product: Albuterol 2.5mg / Ipratropium 0.75mg /Budesonide 0.5mg (3ML Vial)
Model:
Recall #: D-0511-2020
Lot Numbers:
All Lots
Product: Albuterol 2.5mg / Ipratropium 0.75mg /Budesonide 0.25mg (3ML Vial)
Model:
Recall #: D-0512-2020
Lot Numbers:
All Lots
Product: Albuterol 2.5mg / Budesonide 0.5mg (3ML Vial)
Model:
Recall #: D-0513-2020
Lot Numbers:
All Lots
Product: Albuterol 1.25mg / Ipratropium 0.5mg/ Budesonide 0.25mg (3ML Vial)
Model:
Recall #: D-0514-2020
Lot Numbers:
All Lots
Product: Albuterol 1.25mg / Ipratropium 0.5mg (2ML Vial)
Model:
Recall #: D-0515-2020
Lot Numbers:
All Lots
Product: Albuterol 2.5mg / Ipratropium 0.75mg/ Triamcinolone 0.5 mg (3ML Vial)
Model:
Recall #: D-0516-2020
Lot Numbers:
All Lots

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 84284
Status: Resolved
Manufacturer: Integrated Health Concepts Inc. dba Conversio Health
Sold By: Conversio Health; Direct distribution
Manufactured In: United States
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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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.