Why it was recalled
Lack of assurance of sterility; equipment failure led to potential breach in asceptic process.
Product description
0.5% Bupivacaine HCl and Epinephrine 1:200,000 Inj., 50 mL, Multiple-dose Fliptop Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045. NDC #0409-9046-01.
Lot numbers, UPCs & expiration codes
Lot #32-484-EV, 32-485-EV Exp: 2/2015.
Where it was sold
US Nationwide.
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-395-2014
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Oct 11, 2013
- FDA report date
- Jan 8, 2014
- Quantity
- 65109 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Hospira Inc.
Original FDA data
Every field from FDA enforcement report D-395-2014, exactly as published.
Show all FDA fields
- City
- Lake Forest
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 67045
- Address
- 375 N Field Dr
- Code information
- Lot #32-484-EV, 32-485-EV Exp: 2/2015.
- Postal code
- 60045-2513
- Report date
- Jan 8, 2014
- Product type
- Drugs
- Recall number
- D-395-2014
- Classification
- Class II
- Recalling firm
- Hospira Inc.
- Product quantity
- 65109 vials
- Termination date
- Nov 10, 2014
- Reason for recall
- Lack of assurance of sterility; equipment failure led to potential breach in asceptic process.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 0.5% Bupivacaine HCl and Epinephrine 1:200,000 Inj., 50 mL, Multiple-dose Fliptop Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045. NDC #0409-9046-01.
- Distribution pattern
- US Nationwide.
- Recall initiation date
- Oct 11, 2013
- Initial firm notification
- Letter
- Center classification date
- Jan 2, 2014