D-0416-2022 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- February 2, 2022
- Initiation Date
- December 6, 2021
- Termination Date
- June 7, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6535 vials
Product Description
Phenylephrine HCl, 1mg/10mL (0.1mg/mL), 10 mL per syringe, Single Use Syringe for IV Injection, Edge Pharma, LLC, 856 Hercules Dr, Colchester, VT 05446 NDC 05446-1544-10
Reason for Recall
Lack of Assurance of Sterility
Distribution Pattern
nationwide
Code Information
08-2021-26@3 12/16/2021, 09-2021-16@5 12/29/2021, 10-2021-07@2 01/19/2022 & 10-2021-22@1 02/03/2022.