Why it was recalled
Presence of Particulate Matter: Report of a vial containing visible particulate matter embedded in the glass wall which has the potential to dislodge resulting in the presence of particulate matter in the product.
Product description
Lidocaine HCl Injection, USP, 1% (10 mg/mL), 30 mL Single-dose Teartop Vial, packaged in 25-count vials per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045; NDC 0409-4279-02.
Lot numbers, UPCs & expiration codes
Lot #: 14-277-DK*, Exp 02/01/14; * may be followed by 01
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-099-2013
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Oct 4, 2012
- FDA report date
- Dec 26, 2012
- Quantity
- 120,350 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Hospira, Inc.
Original FDA data
Every field from FDA enforcement report D-099-2013, exactly as published.
Show all FDA fields
- City
- Lake Forest
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 63913
- Address
- 600 N Field Dr Bldg J45
- Code information
- Lot #: 14-277-DK*, Exp 02/01/14; * may be followed by 01
- Postal code
- 60045
- Report date
- Dec 26, 2012
- Product type
- Drugs
- Recall number
- D-099-2013
- Classification
- Class II
- Recalling firm
- Hospira, Inc.
- Product quantity
- 120,350 vials
- Termination date
- May 8, 2014
- Reason for recall
- Presence of Particulate Matter: Report of a vial containing visible particulate matter embedded in the glass wall which has the potential to dislodge resulting in the presence of particulate matter in the product.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Lidocaine HCl Injection, USP, 1% (10 mg/mL), 30 mL Single-dose Teartop Vial, packaged in 25-count vials per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045; NDC 0409-4279-02.
- Distribution pattern
- Nationwide
- Recall initiation date
- Oct 4, 2012
- Initial firm notification
- Letter
- Center classification date
- Dec 20, 2012