Edge Pharma, LLC recalls Methacholine Challenge 5-Syringe Test Kit, Sterile Inhalation Solution, Preservative Free, 3 mL per syringe,(NDC 05446-
Recalled February 2, 2022 · FDA recall D-0405-2022 · Edge Pharma
Hazard
Lack of Assurance of Sterility · FDA Class II
Units
1007 syringes
Sold at
nationwide
Description
Lack of Assurance of Sterility
Product
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
Manufacturer(s)
Edge Pharma, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →