Methacholine Challenge 5-Syringe Test Kits recalled over temperature-control failures

Recall date

February 17, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Edge Pharma, LLC recalls Methacholine Challenge 5-Syringe Test Kits, Sterile Inhalation Solution, Preservative Free, 3 mL per syringe, Edge Phar…

Recall number

D-0306-2021

FDA classification

Class III

Brand / firm

Edge Pharma, LLC

Sold / distributed

Nationwide in the US

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

Class III means the product violates regulations but is not likely to cause harm.

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