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 Pharm
Reason for recall: Lack of Assurance of Sterility
Recall initiated: 20211206
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated