Why it was recalled
Presence of Particulate Matter: Confirmed customer complaint that orange and black particulates, identified as iron oxide, were found embedded within the glass vial and floating in solution.
Product description
1% LIDOCAINE HCl Injection, USP, Preservative-Free, 10 mg/mL, 30 mL Single-dose vials, packaged in 25-count cartons, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-4279-02.
Lot numbers, UPCs & expiration codes
Lot number: 31-427-DK, Exp 01JUL2015.
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-0382-2015
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Apr 18, 2014
- FDA report date
- Feb 11, 2015
- Quantity
- 120,900 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Hospira Inc.
Original FDA data
Every field from FDA enforcement report D-0382-2015, exactly as published.
Show all FDA fields
- City
- Lake Forest
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 69327
- Address
- 375 N Field Dr
- Code information
- Lot number: 31-427-DK, Exp 01JUL2015.
- Postal code
- 60045-2513
- Report date
- Feb 11, 2015
- Product type
- Drugs
- Recall number
- D-0382-2015
- Classification
- Class I
- Recalling firm
- Hospira Inc.
- Product quantity
- 120,900 vials
- Termination date
- Nov 7, 2017
- Reason for recall
- Presence of Particulate Matter: Confirmed customer complaint that orange and black particulates, identified as iron oxide, were found embedded within the glass vial and floating in solution.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 1% LIDOCAINE HCl Injection, USP, Preservative-Free, 10 mg/mL, 30 mL Single-dose vials, packaged in 25-count cartons, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-4279-02.
- Distribution pattern
- Nationwide.
- Recall initiation date
- Apr 18, 2014
- Initial firm notification
- Press Release
- Center classification date
- Jan 30, 2015