FDAClass IIFebruary 2, 2022

Methacholine Challenge 5-Syringe Test Kit recall: Sterility Concern

Methacholine Challenge 5-Syringe Test Kit, Sterile Inhalation Solution, Preservative Free, 3 mL per syringe,(NDC 05446-1600-05), Kit includes…

Why was Methacholine Challenge 5-Syringe Test Kit recalled?

Lack of Assurance of Sterility

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
Methacholine Challenge 5-Syringe Test Kit, Sterile Inhalation Solution, Preservative Free, 3 mL per syringe,(NDC 05446-1600-05), Kit includes…
Recalling firm
Edge Pharma, LLC
Quantity
1007 syringes
Distribution
nationwide
Recall date
February 2, 2022
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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