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Class II: temporary or reversible health riskTerminated

Hospira Inc., A Pfizer METRONIDazole Injection Recall

METRONIDazole Injection, USP 500 mg (5 mg/mL) in 100 mL Single Dose Flexible Container,…

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

Risk level
Class II
Reported by FDA
Mar 1, 2017
Recall ID
D-0480-2017
Check your lot numberHow we source this data

Summary

Hospira Inc., A Pfizer recalled METRONIDazole Injection starting Feb 10, 2017. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0480-2017 on Mar 1, 2017. Reason: Lack of Sterility Assurance: customer report of leaking bag. Status: Terminated.

Why it was recalled

Lack of Sterility Assurance: customer report of leaking bag

Product description

METRONIDazole Injection, USP 500 mg (5 mg/mL) in 100 mL Single Dose Flexible Container, Rx only, For IV Use, Hospira Inc., Lake Forest, IL --- NDC 0409-7811-24

Lot numbers, UPCs & expiration codes

Lot: 54-054-JT, 6/1/2017

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-0480-2017
Classification
Class II
Status
Terminated
Recall initiated
Feb 10, 2017
FDA report date
Mar 1, 2017
Quantity
578,784 bags
Recall type
Voluntary: Firm initiated
Recalling firm
Hospira Inc., A Pfizer Company

Original FDA data

Every field from FDA enforcement report D-0480-2017, exactly as published.

Show all FDA fields
City
Lake Forest
State
IL
Status
Terminated
Country
United States
Event ID
76460
Address
275 N Field Dr
Code information
Lot: 54-054-JT, 6/1/2017
Postal code
60045-2579
Report date
Mar 1, 2017
Product type
Drugs
Recall number
D-0480-2017
Classification
Class II
Recalling firm
Hospira Inc., A Pfizer Company
Product quantity
578,784 bags
Termination date
Apr 3, 2019
Reason for recall
Lack of Sterility Assurance: customer report of leaking bag
Voluntary / mandated
Voluntary: Firm initiated
Product description
METRONIDazole Injection, USP 500 mg (5 mg/mL) in 100 mL Single Dose Flexible Container, Rx only, For IV Use, Hospira Inc., Lake Forest, IL --- NDC 0409-7811-24
Distribution pattern
Nationwide and Puerto Rico
Recall initiation date
Feb 10, 2017
Initial firm notification
Letter
Center classification date
Feb 17, 2017

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0480-2017, published Mar 1, 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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