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Class II: temporary or reversible health riskTerminated

Hospira DOBUTamine in 5% Dextrose Injection Recall

DOBUTamine in 5% Dextrose Injection, USP, 250 mg Total, 1000 mcg/mL 250 mL bag, Rx only…

Hospira Inc. · Lake Forest, IL

Risk level
Class II
Reported by FDA
Jun 12, 2013
Recall ID
D-502-2013
Check your lot numberHow we source this data

Summary

Hospira recalled DOBUTamine in 5% Dextrose Injection starting Apr 30, 2013. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-502-2013 on Jun 12, 2013. Reason: Lack of Assurance of Sterility: Confirmed report of leaking in the primary container. Status: Terminated.

Why it was recalled

Lack of Assurance of Sterility: Confirmed report of leaking in the primary container.

Product description

DOBUTamine in 5% Dextrose Injection, USP, 250 mg Total, 1000 mcg/mL 250 mL bag, Rx only, HOPIRA, INC., LAKE FOREST, IL 60045 NDC 0409-2346-32

Lot numbers, UPCs & expiration codes

Lot 11-309-KL

Where it was sold

Nationwide and Puerto Rico

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-502-2013
Classification
Class II
Status
Terminated
Recall initiated
Apr 30, 2013
FDA report date
Jun 12, 2013
Quantity
44,748 bags
Recall type
Voluntary: Firm initiated
Recalling firm
Hospira Inc.

Original FDA data

Every field from FDA enforcement report D-502-2013, exactly as published.

Show all FDA fields
City
Lake Forest
State
IL
Status
Terminated
Country
United States
Event ID
65225
Address
275 N Field Dr
Code information
Lot 11-309-KL
Postal code
60045-2579
Report date
Jun 12, 2013
Product type
Drugs
Recall number
D-502-2013
Classification
Class II
Recalling firm
Hospira Inc.
Product quantity
44,748 bags
Termination date
Oct 8, 2014
Reason for recall
Lack of Assurance of Sterility: Confirmed report of leaking in the primary container.
Voluntary / mandated
Voluntary: Firm initiated
Product description
DOBUTamine in 5% Dextrose Injection, USP, 250 mg Total, 1000 mcg/mL 250 mL bag, Rx only, HOPIRA, INC., LAKE FOREST, IL 60045 NDC 0409-2346-32
Distribution pattern
Nationwide and Puerto Rico
Recall initiation date
Apr 30, 2013
Initial firm notification
Letter
Center classification date
Jun 3, 2013

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-502-2013, published Jun 12, 2013. 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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