Methacholine Challenge 5-Syringe Test Kits — Class III drug recall D-0306-2021
Terminated recall by Edge Pharma, LLC, reported 2021-03-24, distributed nationwide. Temperature Abuse; labeled with the incorrect room temperature (15-25 ¿C) storage conditions rather than the c
| Recall number | D-0306-2021 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Edge Pharma, LLC, Colchester, VT, United States |
| Recall initiated | 2021-02-17 |
| Classified | 2021-03-18 |
| Reported by FDA | 2021-03-24 |
| Terminated | 2021-06-10 |
| Distributed | Nationwide (US) |
| Quantity | 213 kits |
| Reason classes | labeling, temperature control |
| NDC | 05446-1600-05 |
| Expiration dates | 2021-03-02, 2021-03-30 |
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0306-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.