FDA-Drug2021-03-24Class III
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
Edge Pharma, LLC
Hazard
Temperature Abuse; labeled with the incorrect room temperature (15-25 ¿C) storage conditions rather than the correct refrigerated (2 - 8 ¿C) storage conditions
Sold states
Nationwide in the US
Affected count
213 kits
Manufactured in
856 Hercules Dr, N/A, Colchester, VT, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0306-2021Don't want to check this manually?
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