Why it was recalled
Presence of Particulate Matter: A confirmed customer complaint reported the presence of a brown, rust-colored particle embedded at the bottom of the glass vial.
Product description
Bupivacaine HCl Inj., USP, 0.5% (5 mg/mL), 30 mL Single-dose Preservative-Free, For Nerve Block, Caudal, and Epidural Anesthesia, Not for Spinal Anesthesia, Rx Only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-1162-02
Lot numbers, UPCs & expiration codes
LOT 37-268-DK; Exp: 1JAN2016
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-1588-2014
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Sep 4, 2014
- FDA report date
- Sep 24, 2014
- Quantity
- 75,000 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Hospira Inc.
Original FDA data
Every field from FDA enforcement report D-1588-2014, exactly as published.
Show all FDA fields
- City
- Lake Forest
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 69247
- Address
- 275 N Field Dr
- Code information
- LOT 37-268-DK; Exp: 1JAN2016
- Postal code
- 60045-2579
- Report date
- Sep 24, 2014
- Product type
- Drugs
- Recall number
- D-1588-2014
- Classification
- Class II
- Recalling firm
- Hospira Inc.
- Product quantity
- 75,000 vials
- Termination date
- Jul 23, 2015
- Reason for recall
- Presence of Particulate Matter: A confirmed customer complaint reported the presence of a brown, rust-colored particle embedded at the bottom of the glass vial.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Bupivacaine HCl Inj., USP, 0.5% (5 mg/mL), 30 mL Single-dose Preservative-Free, For Nerve Block, Caudal, and Epidural Anesthesia, Not for Spinal Anesthesia, Rx Only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-1162-02
- Distribution pattern
- Nationwide
- Recall initiation date
- Sep 4, 2014
- Initial firm notification
- Letter
- Center classification date
- Sep 17, 2014