Class II · Moderate risk
Trypan Blue 0.03%
CGMP Deviations
Methacholine Challenge 5-Syringe Test Kit
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility
Cause type: Sterility / contamination
A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections. All sterility / contamination recalls.
What was recalled
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
Affected NDCs
5446-1241-01
5446-1246-01
5446-1247-01
5446-1248-01
5446-1249-01
5446-1600-05
Compare with the code on your package — it is the most precise check available.
- Recalling firm
- Edge Pharma, LLC
- NDC code
- 05446-1600-05
- Origin
- VT, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0405-2022 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other recalls by Edge Pharma, LLC
All 2021 recalls
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Vancomycin HCl Oral Solution
CGMP Deviations
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Tetracaine HCl Nasal Solution
CGMP Deviations
Class II · Moderate risk
Promethazine HCl Topical Ointment
CGMP Deviations
Other sterility / contamination recalls from 2021
All sterility / contamination recalls
Class II · Moderate risk
Norepinephrine Bitartrate Injection USP 4 mg/4 mL
Lack of Assurance of Sterility
Class II · Moderate risk
MethylPREDNISolone Acetate Injectable Suspension USP 400 mg/10mL
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Class II · Moderate risk
Medroxyprogesterone Acetate Injection
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Class II · Moderate risk
Vancomycin HCl in 0.9% Sodium Chloride Injection
Lack of Assurance of Sterility
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