Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Methacholine Challenge 5-Syringe Test Kit Recalled by Edge Pharma, LLC Due to Lack of Assurance of Sterility
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Edge Pharma, LLC directly.
Affected Products
Methacholine Challenge 5-Syringe Test Kit, Sterile Inhalation Solution, Preservative Free, 3 mL per syringe,(NDC 05446-1600-05), Kit includes; individual syringe: Methacholine Chloride,16 mg/mL (contains 48 mg) NDC 05446-1241-01; Methacholine Chloride 4 mg/mL (contains 12mg), NDC 05446-1246-01; Methacholine chloride 1mg/mL (contains 3 mg), NDC 05446-1247-01; Methacholine chloride 0.25mg/mL (contains 0.75mg), NDC 05446-1248-01; and Methacholine chloride 0.0625mg/mL NDC 05446-1249-01 Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446
Quantity: 1007 syringes
Why Was This Recalled?
Lack of Assurance of Sterility
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Edge Pharma, LLC
Edge Pharma, LLC has 62 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report