Recalls / Class II
Class IID-1562-2020
Product
Vancomycin HCL 1.5 mg Edge Pharma, LLC 856 Hercules Dr. Colchester, VT 05446 NDC 05446-1458-01
- Affected lot / code info
- Lot # 06-2020-04@2 BUD 09-16-2020
Why it was recalled
Labeling: Label Error on Declared Strength
Recalling firm
- Firm
- Edge Pharma, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 856 Hercules Dr, Colchester, Vermont 05446-8014
Distribution
- Quantity
- 5 IV bags
- Distribution pattern
- WI
Timeline
- Recall initiated
- 2020-07-02
- FDA classified
- 2020-09-07
- Posted by FDA
- 2020-09-16
- Terminated
- 2023-06-07
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1562-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.