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Class I: serious health riskTerminated

Hospira 1% LIDOCAINE HCl Injection Recall

1% LIDOCAINE HCl Injection, USP, 10 mg/mL, 30 mL Single-dose, Preservative-Free glass v…

Hospira Inc. · Lake Forest, IL

Risk level
Class I
Reported by FDA
Feb 25, 2015
Recall ID
D-0391-2015
Check your lot numberHow we source this data

Summary

Hospira recalled 1% LIDOCAINE HCl Injection starting Oct 16, 2014. The FDA classified it as Class I (serious health risk) and published enforcement report D-0391-2015 on Feb 25, 2015. Reason: Presence of particulate matter: A returned customer sample was evaluated and found to have human hair attached to a pinched area of the stopper. Status: Terminated.

Why it was recalled

Presence of particulate matter: A returned customer sample was evaluated and found to have human hair attached to a pinched area of the stopper.

Product description

1% LIDOCAINE HCl Injection, USP, 10 mg/mL, 30 mL Single-dose, Preservative-Free glass vial (Twenty-five (25) units per box/fifty (50) units per case, NDC 0409-4279-02, Hospira, Inc., Lake Forest, IL 60045

Lot numbers, UPCs & expiration codes

Lot# 40-316-DK, Exp 01APR2016

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-0391-2015
Classification
Class I
Status
Terminated
Recall initiated
Oct 16, 2014
FDA report date
Feb 25, 2015
Quantity
100,100 units
Recall type
Voluntary: Firm initiated
Recalling firm
Hospira Inc.

Original FDA data

Every field from FDA enforcement report D-0391-2015, exactly as published.

Show all FDA fields
City
Lake Forest
State
IL
Status
Terminated
Country
United States
Event ID
69567
Address
275 N Field Dr
Code information
Lot# 40-316-DK, Exp 01APR2016
Postal code
60045-2579
Report date
Feb 25, 2015
Product type
Drugs
Recall number
D-0391-2015
Classification
Class I
Recalling firm
Hospira Inc.
Product quantity
100,100 units
Termination date
Dec 29, 2015
Reason for recall
Presence of particulate matter: A returned customer sample was evaluated and found to have human hair attached to a pinched area of the stopper.
Voluntary / mandated
Voluntary: Firm initiated
Product description
1% LIDOCAINE HCl Injection, USP, 10 mg/mL, 30 mL Single-dose, Preservative-Free glass vial (Twenty-five (25) units per box/fifty (50) units per case, NDC 0409-4279-02, Hospira, Inc., Lake Forest, IL 60045
Distribution pattern
Nationwide
Recall initiation date
Oct 16, 2014
Initial firm notification
Letter
Center classification date
Feb 13, 2015

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0391-2015, published Feb 25, 2015. View the source record (openFDA) · FDA enforcement reports

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

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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