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Class I: serious health riskTerminated

Hospira Lidocaine HCl Injection Recall

Lidocaine HCl Injection, USP, 2%, 20 mg per mL, packaged in 5-mL single-dose vials, 10…

Hospira Inc. · Lake Forest, IL

Risk level
Class I
Reported by FDA
May 7, 2014
Recall ID
D-1278-2014
Check your lot numberHow we source this data

Summary

Hospira recalled Lidocaine HCl Injection starting Dec 23, 2013. The FDA classified it as Class I (serious health risk) and published enforcement report D-1278-2014 on May 7, 2014. Reason: Presence of Particulate Matter- Confimed customer complaint of particulates embedded in glass container and in contact with product solution. Status: Terminated.

Why it was recalled

Presence of Particulate Matter- Confimed customer complaint of particulates embedded in glass container and in contact with product solution.

Product description

Lidocaine HCl Injection, USP, 2%, 20 mg per mL, packaged in 5-mL single-dose vials, 10 vials per box, Rx Only, Hospira, Inc., Lake Forest, IL. 60045, NDC 0409-2066-05.

Lot numbers, UPCs & expiration codes

Lot 32135DD; Exp 08/15

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-1278-2014
Classification
Class I
Status
Terminated
Recall initiated
Dec 23, 2013
FDA report date
May 7, 2014
Quantity
68,350 vials
Recall type
Voluntary: Firm initiated
Recalling firm
Hospira Inc.

Original FDA data

Every field from FDA enforcement report D-1278-2014, exactly as published.

Show all FDA fields
City
Lake Forest
State
IL
Status
Terminated
Country
United States
Event ID
67140
Address
275 N Field Dr
Code information
Lot 32135DD; Exp 08/15
Postal code
60045-2579
Report date
May 7, 2014
Product type
Drugs
Recall number
D-1278-2014
Classification
Class I
Recalling firm
Hospira Inc.
Product quantity
68,350 vials
Termination date
Oct 7, 2014
Reason for recall
Presence of Particulate Matter- Confimed customer complaint of particulates embedded in glass container and in contact with product solution.
Voluntary / mandated
Voluntary: Firm initiated
Product description
Lidocaine HCl Injection, USP, 2%, 20 mg per mL, packaged in 5-mL single-dose vials, 10 vials per box, Rx Only, Hospira, Inc., Lake Forest, IL. 60045, NDC 0409-2066-05.
Distribution pattern
Nationwide
Recall initiation date
Dec 23, 2013
Initial firm notification
Press Release
Center classification date
Apr 27, 2014

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1278-2014, published May 7, 2014. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

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