FDAFDA · Food and drugs·Recall number D-0306-2021
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
Published March 24, 2021 · Recall initiated: February 17, 2021
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Temperature Abuse; labeled with the incorrect room temperature (15-25 ¿C) storage conditions rather than the correct refrigerated (2 - 8 ¿C) storage conditions
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Edge Pharma, LLC
- Distributor
- Nationwide in the US
- Lot
- Lot # 12-2020-16@10, BUD 3-30-21 Lot # 11-2020-18@11, BUD 3-02-21
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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