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Class I: serious health riskTerminated

Hospira 0.25% Bupivacaine HCl Injection Recall

0.25% Bupivacaine HCl Injection, USP, 2.5 mg/mL, 30 mL, Single-dose, Hospira Inc., Lake…

Hospira Inc. · Lake Forest, IL

Risk level
Class I
Reported by FDA
Dec 25, 2013
Recall ID
D-380-2014
Check your lot numberHow we source this data

Summary

Hospira recalled 0.25% Bupivacaine HCl Injection starting Jul 12, 2013. The FDA classified it as Class I (serious health risk) and published enforcement report D-380-2014 on Dec 25, 2013. Reason: Presence of particulate matter: visible free floating and partially embedded particulate matter in the glass vials. Status: Terminated.

Why it was recalled

Presence of particulate matter: visible free floating and partially embedded particulate matter in the glass vials.

Product description

0.25% Bupivacaine HCl Injection, USP, 2.5 mg/mL, 30 mL, Single-dose, Hospira Inc., Lake Forest, IL 60045, NDC 0409-1159-02

Lot numbers, UPCs & expiration codes

Lot # 18-136-DK; Exp. 6/14

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-380-2014
Classification
Class I
Status
Terminated
Recall initiated
Jul 12, 2013
FDA report date
Dec 25, 2013
Quantity
118,100 vials
Recall type
Voluntary: Firm initiated
Recalling firm
Hospira Inc.

Original FDA data

Every field from FDA enforcement report D-380-2014, exactly as published.

Show all FDA fields
City
Lake Forest
State
IL
Status
Terminated
Country
United States
Event ID
66260
Address
275 N Field Dr
Code information
Lot # 18-136-DK; Exp. 6/14
Postal code
60045-2579
Report date
Dec 25, 2013
Product type
Drugs
Recall number
D-380-2014
Classification
Class I
Recalling firm
Hospira Inc.
Product quantity
118,100 vials
Termination date
Feb 3, 2015
Reason for recall
Presence of particulate matter: visible free floating and partially embedded particulate matter in the glass vials.
Voluntary / mandated
Voluntary: Firm initiated
Product description
0.25% Bupivacaine HCl Injection, USP, 2.5 mg/mL, 30 mL, Single-dose, Hospira Inc., Lake Forest, IL 60045, NDC 0409-1159-02
Distribution pattern
Nationwide
Recall initiation date
Jul 12, 2013
Initial firm notification
Letter
Center classification date
Dec 18, 2013

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-380-2014, published Dec 25, 2013. View the source record (openFDA) · FDA enforcement reports

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

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