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
Reported: March 24, 2021 Initiated: February 17, 2021 #D-0306-2021
Product Description
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
Details
- Recalling Firm
- Edge Pharma, LLC
- Units Affected
- 213 kits
- Distribution
- Nationwide in the US
- Location
- Colchester, VT
Frequently Asked Questions
What product 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. Recalled by Edge Pharma, LLC. Units affected: 213 kits.
Why was this product recalled? ▼
Temperature Abuse; labeled with the incorrect room temperature (15-25 ¿C) storage conditions rather than the correct refrigerated (2 - 8 ¿C) storage conditions
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on March 24, 2021. Severity: Low. Recall number: D-0306-2021.
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