# FDA recall D-0306-2021

> **Edge Pharma, LLC** · Class III · drug recall initiated 2021-02-17.

## Product

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

## Reason for recall

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

## Distribution

Nationwide in the US

## Key facts

- **Recall number:** D-0306-2021
- **Recalling firm:** Edge Pharma, LLC
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2021-02-17
- **Report date:** 2021-03-24
- **Termination date:** 2021-06-10

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Colchester, VT, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0306-2021

## Citation

> AI Analytics. FDA recall D-0306-2021. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/D-0306-2021. Source: US FDA. Licensed CC0.

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