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Class II: temporary or reversible health riskTerminated

Hospira 0.9% Sodium Chloride Injection Recall

0.9% Sodium Chloride Injection USP, 50 mL ADD-Vantage Unit, Rx only, Manufactured by Ho…

Hospira Inc. · Lake Forest, IL

Risk level
Class II
Reported by FDA
Jul 22, 2015
Recall ID
D-1240-2015
Check your lot numberHow we source this data

Summary

Hospira recalled 0.9% Sodium Chloride Injection starting Jul 2, 2015. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-1240-2015 on Jul 22, 2015. Reason: Lack of assurance of sterility: Potential channel leaks near the threaded vial port. Status: Terminated.

Why it was recalled

Lack of assurance of sterility: Potential channel leaks near the threaded vial port.

Product description

0.9% Sodium Chloride Injection USP, 50 mL ADD-Vantage Unit, Rx only, Manufactured by Hospira, Inc., Ausitn, TX 78728, NDC 00409-7101-68

Lot numbers, UPCs & expiration codes

Lot #: 49-084-JT; 49-119-JT

Where it was sold

United States

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-1240-2015
Classification
Class II
Status
Terminated
Recall initiated
Jul 2, 2015
FDA report date
Jul 22, 2015
Quantity
314600 bags
Recall type
Voluntary: Firm initiated
Recalling firm
Hospira Inc.

Original FDA data

Every field from FDA enforcement report D-1240-2015, exactly as published.

Show all FDA fields
City
Lake Forest
State
IL
Status
Terminated
Country
United States
Event ID
71629
Address
275 N Field Dr
Code information
Lot #: 49-084-JT; 49-119-JT
Postal code
60045-2579
Report date
Jul 22, 2015
Product type
Drugs
Recall number
D-1240-2015
Classification
Class II
Recalling firm
Hospira Inc.
Product quantity
314600 bags
Termination date
Nov 17, 2016
Reason for recall
Lack of assurance of sterility: Potential channel leaks near the threaded vial port.
Voluntary / mandated
Voluntary: Firm initiated
Product description
0.9% Sodium Chloride Injection USP, 50 mL ADD-Vantage Unit, Rx only, Manufactured by Hospira, Inc., Ausitn, TX 78728, NDC 00409-7101-68
Distribution pattern
United States
Recall initiation date
Jul 2, 2015
Initial firm notification
Letter
Center classification date
Jul 15, 2015

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1240-2015, published Jul 22, 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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