Drug product
Vancomycin HCl Oral Solution (PF) 125mg / 2.5mL (50 mg/mL), 2.5 mL per syringe, Single Dose Syringe for Oral Use Only, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1348-01
D-0448-2022
Product summary
- Firm
- Edge Pharma, LLC
- Event
- Event 89172
- Status
- Terminated
- Classification
- Class II
- Quantity
- 6925 syringes
- Official record key
drug-enforcement:D-0448-2022
Official wording
Reason: CGMP Deviations
Code information: 09-2021-10@3 12-09-2021, 09-2021-17@6 12-16-2021, 09-2021-24@8 12-23-2021, 09-2021-30@7 12-29-2021 & 10-2021-13@6 01-11-2022 .
Distribution pattern: nationwide
Derived failure modes
-
Manufacturing or process control
CGMP Deviations