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Class I: serious health riskTerminated

Hospira 0.9% Sodium Chloride Injection Recall

0.9% Sodium Chloride Injection, USP, 250 mL, Rx Only, Hospira Inc., Lake Forest, IL, 60…

Hospira Inc. · Lake Forest, IL

Risk level
Class I
Reported by FDA
Apr 29, 2015
Recall ID
D-0969-2015
Check your lot numberHow we source this data

Summary

Hospira recalled 0.9% Sodium Chloride Injection starting Jan 20, 2015. The FDA classified it as Class I (serious health risk) and published enforcement report D-0969-2015 on Apr 29, 2015. Reason: Presence of Particulate Matter; Hospira has identified the particulate as a human hair, sealed in the bag at the additive port area. Status: Terminated.

Why it was recalled

Presence of Particulate Matter; Hospira has identified the particulate as a human hair, sealed in the bag at the additive port area.

Product description

0.9% Sodium Chloride Injection, USP, 250 mL, Rx Only, Hospira Inc., Lake Forest, IL, 60045, USA, NDC 0409-7983-02

Lot numbers, UPCs & expiration codes

Lot #: 44-002-JT (the lot number may be followed by 01 to 99), Exp 08/01/2016

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-0969-2015
Classification
Class I
Status
Terminated
Recall initiated
Jan 20, 2015
FDA report date
Apr 29, 2015
Quantity
661,128 containers
Recall type
Voluntary: Firm initiated
Recalling firm
Hospira Inc.

Original FDA data

Every field from FDA enforcement report D-0969-2015, exactly as published.

Show all FDA fields
City
Lake Forest
State
IL
Status
Terminated
Country
United States
Event ID
70303
Address
275 N Field Dr
Code information
Lot #: 44-002-JT (the lot number may be followed by 01 to 99), Exp 08/01/2016
Postal code
60045-2579
Report date
Apr 29, 2015
Product type
Drugs
Recall number
D-0969-2015
Classification
Class I
Recalling firm
Hospira Inc.
Product quantity
661,128 containers
Termination date
Jan 17, 2017
Reason for recall
Presence of Particulate Matter; Hospira has identified the particulate as a human hair, sealed in the bag at the additive port area.
Voluntary / mandated
Voluntary: Firm initiated
Product description
0.9% Sodium Chloride Injection, USP, 250 mL, Rx Only, Hospira Inc., Lake Forest, IL, 60045, USA, NDC 0409-7983-02
Distribution pattern
Nationwide
Recall initiation date
Jan 20, 2015
Initial firm notification
Press Release
Center classification date
Apr 23, 2015

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0969-2015, published Apr 29, 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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