Phenylephrine HCl 0.5 mg/5mL, (0.1 mg/mL), 5 mL per syringe, Single Use Syringe for IV Injection, Edge Pharma, LLC, 856 Hercules Dr, Colchester, VT 05446, NDC 05446-1545-05
Reported: February 2, 2022 Initiated: December 6, 2021 #D-0415-2022
Product Description
Phenylephrine HCl 0.5 mg/5mL, (0.1 mg/mL), 5 mL per syringe, Single Use Syringe for IV Injection, Edge Pharma, LLC, 856 Hercules Dr, Colchester, VT 05446, NDC 05446-1545-05
Reason for Recall
Lack of Assurance of Sterility
Details
- Recalling Firm
- Edge Pharma, LLC
- Units Affected
- 3747 syringes
- Distribution
- nationwide
- Location
- Colchester, VT
Frequently Asked Questions
What product was recalled? ▼
Phenylephrine HCl 0.5 mg/5mL, (0.1 mg/mL), 5 mL per syringe, Single Use Syringe for IV Injection, Edge Pharma, LLC, 856 Hercules Dr, Colchester, VT 05446, NDC 05446-1545-05. Recalled by Edge Pharma, LLC. Units affected: 3747 syringes.
Why was this product recalled? ▼
Lack of Assurance of Sterility
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on February 2, 2022. Severity: Moderate. Recall number: D-0415-2022.
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