Recall archive / FDA drug enforcement
Methacholine Challenge 5-Syringe Test Kit, Sterile Inhalation Solution, Preservative Free, 3 mL per syringe,(NDC 0544... — FDA record D-0405-2022
Reported terminated
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Dec 6, 2021. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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
- Reason
- Lack of Assurance of Sterility
- Classification
- Class II
- Recalling firm
- Edge Pharma, LLC
- Quantity
- 1007 syringes
- Agency-reported status
- Terminated
- Source record identifier
- D-0405-2022
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 09-2021-03@6 12/16/2021 & 10-2021-06@7 01/18/2022 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
nationwide
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Feb 2, 2022
- Recall initiation date
- Dec 6, 2021
- Center classification date
- Jan 24, 2022
- Termination date
- Jun 7, 2023
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.