Recalls / Class II
Class IID-0416-2022
Product
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
- Affected lot / code info
- 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.
Why it was recalled
Lack of Assurance of Sterility
Recalling firm
- Firm
- Edge Pharma, LLC
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 856 Hercules Dr, Colchester, Vermont 05446-8014
Distribution
- Quantity
- 6535 vials
- Distribution pattern
- nationwide
Timeline
- Recall initiated
- 2021-12-06
- FDA classified
- 2022-01-24
- Posted by FDA
- 2022-02-02
- Terminated
- 2023-06-07
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0416-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.