Reported Feb 2, 2022 · Terminated
Methacholine Challenge 5-Syringe Test Kit, Sterile Inhalation Solution, Preservative Free, 3 mL per syringe,(NDC…
Edge Pharma, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Edge Pharma, LLC · 856 Hercules Dr · Colchester, VT · 05446-8014
Is this the product you have?
Methacholine Challenge 5-Syringe Test Kit, Sterile Inhalation Solution, Preservative Free, 3 mL per syringe,(NDC 05446-1600-05), Kit includes; individual syringe
5 of 5 products
| # | Product as published |
|---|---|
| 1 | Methacholine Chloride,16 mg/mL (contains 48 mg) NDC 05446-1241-01 |
| 2 | Methacholine Chloride 4 mg/mL (contains 12mg), NDC 05446-1246-01 |
| 3 | Methacholine chloride 1mg/mL (contains 3 mg), NDC 05446-1247-01 |
| 4 | Methacholine chloride 0.25mg/mL (contains 0.75mg), NDC 05446-1248-01 |
| 5 | and Methacholine chloride 0.0625mg/mL NDC 05446-1249-01 Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446 |
- Lot codes and dates
- 09-2021-03@6 12/16/2021 & 10-2021-06@7 01/18/2022
- Amount recalled
- 1007 syringes
This recall covers 56 products
The agency filed one notice per product. You are reading one of them; the other 55 are below.
43 more are in the archive.
Where it was sold
- Nationwide
Why it was recalled
Lack of Assurance of Sterility
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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