Vancomycin HCl in 0.9 % Sodium Chloride Injection, USP, 1,250 mg/250 mL, Single Use Bag for IV Injection (Preservative Free), 250 mL pre-filled bag, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1456-01
Reported: February 2, 2022 Initiated: December 6, 2021 #D-0425-2022
Product Description
Vancomycin HCl in 0.9 % Sodium Chloride Injection, USP, 1,250 mg/250 mL, Single Use Bag for IV Injection (Preservative Free), 250 mL pre-filled bag, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1456-01
Reason for Recall
Lack of Assurance of Sterility
Details
- Recalling Firm
- Edge Pharma, LLC
- Units Affected
- 1795 bags
- Distribution
- nationwide
- Location
- Colchester, VT
Frequently Asked Questions
What product was recalled? ▼
Vancomycin HCl in 0.9 % Sodium Chloride Injection, USP, 1,250 mg/250 mL, Single Use Bag for IV Injection (Preservative Free), 250 mL pre-filled bag, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1456-01. Recalled by Edge Pharma, LLC. Units affected: 1795 bags.
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-0425-2022.
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