Recalls / Class III
Class IIID-0306-2021
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
- Affected lot / code info
- Lot # 12-2020-16@10, BUD 3-30-21 Lot # 11-2020-18@11, BUD 3-02-21
Why it was recalled
Temperature Abuse; labeled with the incorrect room temperature (15-25 ¿C) storage conditions rather than the correct refrigerated (2 - 8 ¿C) storage conditions
Recalling firm
- Firm
- Edge Pharma, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 856 Hercules Dr, N/A, Colchester, Vermont 05446-8014
Distribution
- Quantity
- 213 kits
- Distribution pattern
- Nationwide in the US
Timeline
- Recall initiated
- 2021-02-17
- FDA classified
- 2021-03-18
- Posted by FDA
- 2021-03-24
- Terminated
- 2021-06-10
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0306-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.