Edge Pharma, LLC: Drug Recall
Recall #D-0405-2022 · 12/06/2021
Class II: Risk
Recall Details
- Recall Number
- D-0405-2022
- Classification
- Class II
- Product Type
- Drug
- Recalling Firm
- Edge Pharma, LLC
- Status
- Terminated
- Date Initiated
- 12/06/2021
- Location
- Colchester, VT, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1007 syringes
Reason for Recall
Lack of Assurance of Sterility
Product Description
Methacholine Challenge 5-Syringe Test Kit, Sterile Inhalation Solution, Preservative Free, 3 mL per syringe,(NDC 05446-1600-05), Kit includes; individual syringe: Methacholine Chloride,16 mg/mL (contains 48 mg) NDC 05446-1241-01; Methacholine Chloride 4 mg/mL (contains 12mg), NDC 05446-1246-01; Methacholine chloride 1mg/mL (contains 3 mg), NDC 05446-1247-01; Methacholine chloride 0.25mg/mL (contains 0.75mg), NDC 05446-1248-01; and Methacholine chloride 0.0625mg/mL NDC 05446-1249-01 Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446
Distribution Pattern
nationwide
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.