Drug product
Vancomycin HCL 1.5 mg Edge Pharma, LLC 856 Hercules Dr. Colchester, VT 05446 NDC 05446-1458-01
D-1562-2020
Product summary
- Firm
- Edge Pharma, LLC
- Event
- Event 86324
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5 IV bags
- Official record key
drug-enforcement:D-1562-2020
Official wording
Reason: Labeling: Label Error on Declared Strength
Code information: Lot # 06-2020-04@2 BUD 09-16-2020
Distribution pattern: WI
Derived failure modes
-
Labeling or packaging
Labeling: Label Error