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Recall Observatory FDA recall evidence

Drug 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

D-0405-2022

December 06, 2021

Class II

Product summary

Firm
Edge Pharma, LLC
Event
Event 89172
Status
Terminated
Classification
Class II
Quantity
1007 syringes
Official record key
drug-enforcement:D-0405-2022

Official wording

Reason: Lack of Assurance of Sterility

Code information: 09-2021-03@6 12/16/2021 & 10-2021-06@7 01/18/2022

Distribution pattern: nationwide

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility