Edge Pharma, LLC is recalling 213 Methacholine Challenge 5-Syringe Test Kits because the product labels list the wrong storage temperature. The kits were incorrectly labeled for room temperature storage (15-25°C) instead of the required refrigerated conditions (2-8°C). These sterile inhalation solutions are used in medical diagnostic testing, and improper storage can compromise the effectiveness or safety of the medication.
Storing this medication at room temperature instead of in a refrigerator may cause the drug to degrade or lose potency. Using a degraded product in a clinical setting could lead to inaccurate diagnostic results or unexpected health outcomes for patients undergoing lung function testing.
Contact healthcare provider and return product.
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 · 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.