Class II · Moderate risk
Trypan Blue 0.03%
CGMP Deviations
Methacholine Challenge 5-Syringe Test Kits
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Temperature Abuse; labeled with the incorrect room temperature (15-25 ¿C) storage conditions rather than the correct refrigerated (2 - 8 ¿C) storage conditions
Cause type: Temperature excursion
The product was stored or shipped outside its labeled temperature range. Heat or freezing can degrade a drug without any visible change, so it may be weaker than labeled. All temperature excursion recalls.
What was recalled
Methacholine Challenge 5-Syringe Test Kits, Sterile Inhalation Solution, Preservative Free, 3 mL per syringe, Edge Pharma, LLC, 856 Hercules Dr., Dolchester, VT 06448 NDC # 05446-1600-05
Affected NDC
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-0306-2021 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. 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
Class II · Moderate risk
Vancomycin HCl Oral Solution
CGMP Deviations
Class II · Moderate risk
Tetracaine HCl Nasal Solution
CGMP Deviations
Class II · Moderate risk
Promethazine HCl Topical Ointment
CGMP Deviations
Other temperature excursion recalls from 2021
All temperature excursion recalls
Class I · High risk
Enoxaparin Sodium Injection
Temperature Abuse; temperature excursion during shipping
Class I · High risk
Atovaquone Oral Suspension
Temperature abuse: the firm received customer complaints of unusual grittiness in the product.
Class III · Low risk
DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose
Temperature Abuse: Product exposed to temperature outside specified limits.
Class III · Low risk
DELFLEX Peritoneal Dialysis Solution with 4.25% Dextrose
Temperature Abuse: Product exposed to temperature outside specified limits.
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