Class III — Low Risk

Low risk — use of or exposure to this product is not likely to cause adverse health consequences.

Methacholine Challenge 5-Syringe Test Kits Recalled by Edge Pharma, LLC Due to Temperature Abuse; labeled with the incorrect room temperature...

Date: February 17, 2021
Company: Edge Pharma, LLC
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Edge Pharma, LLC directly.

Affected 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

Quantity: 213 kits

Why Was This Recalled?

Temperature Abuse; labeled with the incorrect room temperature (15-25 ¿C) storage conditions rather than the correct refrigerated (2 - 8 ¿C) storage conditions

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Edge Pharma, LLC

Edge Pharma, LLC has 62 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report