Why it was recalled
Presence of Particulate Matter: The product was discolored and contained visible particulates (iron oxide) in the solution and embedded in the glass vial.
Product description
Lidocaine HCl Injection, USP, 2%, 20 mg per mL, Preservative-Free, 5 mL Single-Dose Vial, Rx only, For Infiltration and Nerve Block including Epidural and Caudal, Manufactured by: Hospira, Inc., Lake Forest, IL, 60045, NDC 0409-2066-05
Lot numbers, UPCs & expiration codes
Lot Number: 25-550-DD, Exp: 1JAN2015
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-0020-2015
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Jul 29, 2014
- FDA report date
- Oct 22, 2014
- Quantity
- 109,110 Vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Hospira Inc.
Original FDA data
Every field from FDA enforcement report D-0020-2015, exactly as published.
Show all FDA fields
- City
- Lake Forest
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 68901
- Address
- 275 N Field Dr
- Code information
- Lot Number: 25-550-DD, Exp: 1JAN2015
- Postal code
- 60045-2579
- Report date
- Oct 22, 2014
- Product type
- Drugs
- Recall number
- D-0020-2015
- Classification
- Class I
- Recalling firm
- Hospira Inc.
- Product quantity
- 109,110 Vials
- Termination date
- Mar 17, 2017
- Reason for recall
- Presence of Particulate Matter: The product was discolored and contained visible particulates (iron oxide) in the solution and embedded in the glass vial.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Lidocaine HCl Injection, USP, 2%, 20 mg per mL, Preservative-Free, 5 mL Single-Dose Vial, Rx only, For Infiltration and Nerve Block including Epidural and Caudal, Manufactured by: Hospira, Inc., Lake Forest, IL, 60045, NDC 0409-2066-05
- Distribution pattern
- Nationwide
- Recall initiation date
- Jul 29, 2014
- Initial firm notification
- Press Release
- Center classification date
- Oct 10, 2014