Edge Pharma, LLC: Drug Recall
Recall #D-0306-2021 · 02/17/2021
Class III: Low Risk
Recall Details
- Recall Number
- D-0306-2021
- Classification
- Class III
- Product Type
- Drug
- Recalling Firm
- Edge Pharma, LLC
- Status
- Terminated
- Date Initiated
- 02/17/2021
- Location
- Colchester, VT, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 213 kits
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
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
Distribution Pattern
Nationwide in the US
Other Recalls by Edge Pharma, LLC
- Class II: Risk 12/06/2021
- Class II: Risk 12/06/2021
- Class II: Risk 12/06/2021
- Class II: Risk 12/06/2021
- Class II: Risk 12/06/2021
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.