Recalls / Class II
Class IID-0448-2022
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
- Affected lot / code info
- 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 .
Why it was recalled
CGMP Deviations
Recalling firm
- Firm
- Edge Pharma, LLC
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 856 Hercules Dr, Colchester, Vermont 05446-8014
Distribution
- Quantity
- 6925 syringes
- 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-0448-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.