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Class II: temporary or reversible health riskTerminated

Hospira Propofol Injectable Emulsion Recall

Propofol Injectable Emulsion, 1%, 200 mg/20 mL, (10mg/mL), 20 mL, Single patient infusi…

Hospira Inc. · Lake Forest, IL

Risk level
Class II
Reported by FDA
Feb 4, 2015
Recall ID
D-0381-2015
Check your lot numberHow we source this data

Summary

Hospira recalled Propofol Injectable Emulsion starting Dec 23, 2014. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0381-2015 on Feb 4, 2015. Reason: Presence of Particulate Matter: The firm received a complaint of an embedded particulate in the neck of one vial composed primarily of iron. Status: Terminated.

Why it was recalled

Presence of Particulate Matter: The firm received a complaint of an embedded particulate in the neck of one vial composed primarily of iron.

Product description

Propofol Injectable Emulsion, 1%, 200 mg/20 mL, (10mg/mL), 20 mL, Single patient infusion vial, Contains Benzyl Alcohol, For I.V. Administration, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4699-30

Lot numbers, UPCs & expiration codes

Lot 35-844-DJ, Exp 11/01/2015

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-0381-2015
Classification
Class II
Status
Terminated
Recall initiated
Dec 23, 2014
FDA report date
Feb 4, 2015
Quantity
126,075 vials
Recall type
Voluntary: Firm initiated
Recalling firm
Hospira Inc.

Original FDA data

Every field from FDA enforcement report D-0381-2015, exactly as published.

Show all FDA fields
City
Lake Forest
State
IL
Status
Terminated
Country
United States
Event ID
70179
Address
375 N Field Dr
Code information
Lot 35-844-DJ, Exp 11/01/2015
Postal code
60045-2513
Report date
Feb 4, 2015
Product type
Drugs
Recall number
D-0381-2015
Classification
Class II
Recalling firm
Hospira Inc.
Product quantity
126,075 vials
Termination date
Jul 30, 2015
Reason for recall
Presence of Particulate Matter: The firm received a complaint of an embedded particulate in the neck of one vial composed primarily of iron.
Voluntary / mandated
Voluntary: Firm initiated
Product description
Propofol Injectable Emulsion, 1%, 200 mg/20 mL, (10mg/mL), 20 mL, Single patient infusion vial, Contains Benzyl Alcohol, For I.V. Administration, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4699-30
Distribution pattern
Nationwide
Recall initiation date
Dec 23, 2014
Initial firm notification
Letter
Center classification date
Jan 27, 2015

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0381-2015, published Feb 4, 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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