Why it was recalled
Presence of Particulate Matter: Confirmed customer complaint of discolored solution with visible metal particles embedded in the glass vial and visible in the solution.
Product description
Marcaine (bupivacaine HCl) injection, USP, 0.25%, Preservative-Free, 10 mL (25 mg) Single-dose Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045 USP, NDC 0409-1559-10.
Lot numbers, UPCs & expiration codes
Lot #: 34-440-DD, Exp 10/15
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-1358-2014
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Apr 21, 2014
- FDA report date
- Jun 11, 2014
- Quantity
- 85,680 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Hospira Inc.
Original FDA data
Every field from FDA enforcement report D-1358-2014, exactly as published.
Show all FDA fields
- City
- Lake Forest
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 68048
- Address
- 275 N Field Dr
- Code information
- Lot #: 34-440-DD, Exp 10/15
- Postal code
- 60045-2579
- Report date
- Jun 11, 2014
- Product type
- Drugs
- Recall number
- D-1358-2014
- Classification
- Class I
- Recalling firm
- Hospira Inc.
- Product quantity
- 85,680 vials
- Termination date
- Mar 16, 2017
- Reason for recall
- Presence of Particulate Matter: Confirmed customer complaint of discolored solution with visible metal particles embedded in the glass vial and visible in the solution.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Marcaine (bupivacaine HCl) injection, USP, 0.25%, Preservative-Free, 10 mL (25 mg) Single-dose Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045 USP, NDC 0409-1559-10.
- Distribution pattern
- Nationwide.
- Recall initiation date
- Apr 21, 2014
- Initial firm notification
- Press Release
- Center classification date
- Jun 5, 2014