CLASS II Drug recall · Reported 2 Feb 2022 · FDA Enforcement Report
Methacholine Challenge 5-Syringe Test Kit recalled by Edge Pharma
Edge Pharma is recalling Methacholine Challenge 5-Syringe Test Kit, Sterile Inhalation Solution, Preservative Free, distributed nationwide in the US. The recall was initiated on 6 Dec 2021 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0405-2022
- FDA event ID
- 89172
- Recalling firm
- Edge Pharma, Colchester, VT
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 6 Dec 2021
- FDA classified
- 24 Jan 2022
- Reported
- 2 Feb 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Sterility
Timeline
| 6 Dec 2021 | Recall initiated by company | |
| 24 Jan 2022 | Classified by FDA | +49 days |
| 2 Feb 2022 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Assurance of Sterility
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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
Where it was distributed
nationwide
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility
Which lots are affected?
09-2021-03@6 12/16/2021 & 10-2021-06@7 01/18/2022
Where was it sold?
nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
55 other products · FDA event 89172This product is part of a recall event; the main page for the event is Edetate Disodium (EDTA), Sterile Ophthalmic Solution recalled.
More recalls from Edge Pharma
All 62| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Phenylephrine HCl, Sterile Solution for Injection, (PF) recalled | Edge Pharma | Sterility | Nationwide |
| Drug | CLASS II | Tetracaine HCl Nasal Solution recalled by Edge Pharma | Edge Pharma | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Methotrexate, USP, Sterile Solution for Injection (PF) recalled | Edge Pharma | Sterility | Nationwide |
| Drug | CLASS II | CSF Otic Insufflation Capsule recalled by Edge Pharma | Edge Pharma | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Ceftazidime, Sterile Ophthalmic Solution for Injection recalled | Edge Pharma | Sterility | Nationwide |