Why it was recalled
Presence of Particulate Matter: Oxidized stainless steel found in vial of 1% Lidocaine Hydrochloride Injection, USP.
Product description
1% Lidocaine HCl Injection, USP, 10 mg/mL, NDC 0409-4276-01, Hospira, Inc., Lake Forest, IL 60045.
Lot numbers, UPCs & expiration codes
Lot #25090DK; Exp 01/15
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-1234-2014
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Sep 16, 2013
- FDA report date
- Apr 23, 2014
- Quantity
- 374,500 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Hospira, Inc.
Original FDA data
Every field from FDA enforcement report D-1234-2014, exactly as published.
Show all FDA fields
- City
- Lake Forest
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 66441
- Address
- 600 N Field Dr Bldg J45
- Code information
- Lot #25090DK; Exp 01/15
- Postal code
- 60045
- Report date
- Apr 23, 2014
- Product type
- Drugs
- Recall number
- D-1234-2014
- Classification
- Class I
- Recalling firm
- Hospira, Inc.
- Product quantity
- 374,500 vials
- Termination date
- Nov 4, 2014
- Reason for recall
- Presence of Particulate Matter: Oxidized stainless steel found in vial of 1% Lidocaine Hydrochloride Injection, USP.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 1% Lidocaine HCl Injection, USP, 10 mg/mL, NDC 0409-4276-01, Hospira, Inc., Lake Forest, IL 60045.
- Distribution pattern
- Nationwide
- Recall initiation date
- Sep 16, 2013
- Initial firm notification
- Letter
- Center classification date
- Apr 14, 2014