Why it was recalled
Presence of Particulate Matter: Presence of free-floating and embedded iron oxide particles.
Product description
Bupivacaine Hydrochloride Inj., USP, 0.5% (5 mg/mL), Preservative-Free, 30 mL Single Use Vials, Rx only. HOSPIRA, INC., LAKE FOREST, IL 60045 USA. NDC: 0409-1162-02.
Lot numbers, UPCs & expiration codes
Lot #: 38-515-DK, Expiry: 1 FEB 2016.
Where it was sold
U.S. Nationwide including Guam.
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-1216-2015
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Apr 23, 2015
- FDA report date
- Jul 15, 2015
- Quantity
- 150,950 Vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Hospira Inc.
Original FDA data
Every field from FDA enforcement report D-1216-2015, exactly as published.
Show all FDA fields
- City
- Lake Forest
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 71377
- Address
- 600 N Field Dr
- Code information
- Lot #: 38-515-DK, Expiry: 1 FEB 2016.
- Postal code
- 60045-4835
- Report date
- Jul 15, 2015
- Product type
- Drugs
- Recall number
- D-1216-2015
- Classification
- Class I
- Recalling firm
- Hospira Inc.
- Product quantity
- 150,950 Vials
- Termination date
- Jan 26, 2016
- Reason for recall
- Presence of Particulate Matter: Presence of free-floating and embedded iron oxide particles.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Bupivacaine Hydrochloride Inj., USP, 0.5% (5 mg/mL), Preservative-Free, 30 mL Single Use Vials, Rx only. HOSPIRA, INC., LAKE FOREST, IL 60045 USA. NDC: 0409-1162-02.
- Distribution pattern
- U.S. Nationwide including Guam.
- Recall initiation date
- Apr 23, 2015
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Jul 8, 2015