Why it was recalled
Labeling: Label Error on Declared Strength
Product description
Vancomycin HCL 1.5 mg Edge Pharma, LLC 856 Hercules Dr. Colchester, VT 05446 NDC 05446-1458-01
Lot numbers, UPCs & expiration codes
Lot # 06-2020-04@2 BUD 09-16-2020
Where it was sold
WI
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1562-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 2, 2020
- FDA report date
- Sep 16, 2020
- Quantity
- 5 IV bags
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Edge Pharma, LLC
Original FDA data
Every field from FDA enforcement report D-1562-2020, exactly as published.
Show all FDA fields
- City
- Colchester
- State
- VT
- Status
- Terminated
- Country
- United States
- Event ID
- 86324
- Address
- 856 Hercules Dr
- Code information
- Lot # 06-2020-04@2 BUD 09-16-2020
- Postal code
- 05446-8014
- Report date
- Sep 16, 2020
- Product type
- Drugs
- Recall number
- D-1562-2020
- Classification
- Class II
- Recalling firm
- Edge Pharma, LLC
- Product quantity
- 5 IV bags
- Termination date
- Jun 7, 2023
- Reason for recall
- Labeling: Label Error on Declared Strength
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Vancomycin HCL 1.5 mg Edge Pharma, LLC 856 Hercules Dr. Colchester, VT 05446 NDC 05446-1458-01
- Distribution pattern
- WI
- Recall initiation date
- Jul 2, 2020
- Initial firm notification
- Letter
- Center classification date
- Sep 7, 2020