Why it was recalled
Presence of Particulate Matter: Units of this lot may have visible metal particles embedded in the vial and in the solution causing the product to be discolored.
Product description
Marcaine (bupivacaine HCl) injection, USP, 0.25%, 30 mL single-dose vials-preservative free, packaged in 10-count vials per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1559-30.
Lot numbers, UPCs & expiration codes
Lot 25-220-DD, Exp 1JAN2015
Where it was sold
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-1161-2014
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Oct 18, 2013
- FDA report date
- Mar 26, 2014
- Quantity
- 40,360 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Hospira Inc.
Original FDA data
Every field from FDA enforcement report D-1161-2014, exactly as published.
Show all FDA fields
- City
- Lake Forest
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 66503
- Address
- 275 N Field Dr
- Code information
- Lot 25-220-DD, Exp 1JAN2015
- Postal code
- 60045-2579
- Report date
- Mar 26, 2014
- Product type
- Drugs
- Recall number
- D-1161-2014
- Classification
- Class I
- Recalling firm
- Hospira Inc.
- Product quantity
- 40,360 vials
- Termination date
- Dec 18, 2015
- Reason for recall
- Presence of Particulate Matter: Units of this lot may have visible metal particles embedded in the vial and in the solution causing the product to be discolored.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Marcaine (bupivacaine HCl) injection, USP, 0.25%, 30 mL single-dose vials-preservative free, packaged in 10-count vials per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1559-30.
- Distribution pattern
- Nationwide
- Recall initiation date
- Oct 18, 2013
- Initial firm notification
- Letter
- Center classification date
- Mar 14, 2014