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Class II: temporary or reversible health riskTerminated

Hospira Inc., A Pfizer Levophed norepinephrine bitartrate Recall

Levophed norepinephrine bitartrate, injection, USP, 4 mg /4 mL (1 mg/mL),Rx only, Hosp…

Hospira Inc., A Pfizer Company · Lake Forest, IL

Risk level
Class II
Reported by FDA
Jun 21, 2017
Recall ID
D-0898-2017
Check your lot numberHow we source this data

Summary

Hospira Inc., A Pfizer recalled Levophed norepinephrine bitartrate starting May 18, 2017. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0898-2017 on Jun 21, 2017. Reason: GMP Deviation; A foreign stopper was observed during packaging of a lot of product. Status: Terminated.

Why it was recalled

GMP Deviation; A foreign stopper was observed during packaging of a lot of product.

Product description

Levophed norepinephrine bitartrate, injection, USP, 4 mg /4 mL (1 mg/mL),Rx only, Hospira, Inc. Lake Forest, IL --- NDC 0409-3375-04

Lot numbers, UPCs & expiration codes

720503A, 720603A (Canada only)

Where it was sold

Nationwide, Canada and Singapore

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-0898-2017
Classification
Class II
Status
Terminated
Recall initiated
May 18, 2017
FDA report date
Jun 21, 2017
Quantity
(720503A): 43,200 vials, (720603A): 400 vials
Recall type
Voluntary: Firm initiated
Recalling firm
Hospira Inc., A Pfizer Company

Original FDA data

Every field from FDA enforcement report D-0898-2017, exactly as published.

Show all FDA fields
City
Lake Forest
State
IL
Status
Terminated
Country
United States
Event ID
77288
Address
275 N Field Dr
Code information
720503A, 720603A (Canada only)
Postal code
60045-2579
Report date
Jun 21, 2017
Product type
Drugs
Recall number
D-0898-2017
Classification
Class II
Recalling firm
Hospira Inc., A Pfizer Company
Product quantity
(720503A): 43,200 vials, (720603A): 400 vials
Termination date
May 2, 2019
Reason for recall
GMP Deviation; A foreign stopper was observed during packaging of a lot of product.
Voluntary / mandated
Voluntary: Firm initiated
Product description
Levophed norepinephrine bitartrate, injection, USP, 4 mg /4 mL (1 mg/mL),Rx only, Hospira, Inc. Lake Forest, IL --- NDC 0409-3375-04
Distribution pattern
Nationwide, Canada and Singapore
Recall initiation date
May 18, 2017
Initial firm notification
Letter
Center classification date
Jun 9, 2017

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0898-2017, published Jun 21, 2017. 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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