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Class I: serious health riskOngoing

Hospira Infant 25% DEXTROSE Injection Recall

Infant 25% DEXTROSE Injection, USP, 2

Hospira Inc. · Lake Forest, IL

Risk level
Class I
Reported by FDA
May 31, 2017
Recall ID
D-0862-2017
Check your lot numberHow we source this data

Summary

Hospira recalled Infant 25% DEXTROSE Injection starting Apr 21, 2017. The FDA classified it as Class I (serious health risk) and published enforcement report D-0862-2017 on May 31, 2017. Reason: Presence of Particulate Matter: human hair found within an internal sample syringe. Status: Ongoing.

Why it was recalled

Presence of Particulate Matter: human hair found within an internal sample syringe.

Product description

Infant 25% DEXTROSE Injection, USP, 2.5 g (250 mg/mL), 10 mL Unit of Use Single-dose Syringe per carton, Rx only, Hospira Inc., Lake Forest, IL 60045, NDC 0409-1775-10

Lot numbers, UPCs & expiration codes

Lot 58382EV*, Exp 1OCT 2017, *lot may be followed by 01 or 02

Where it was sold

Nationwide in the USA 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-0862-2017
Classification
Class I
Status
Ongoing
Recall initiated
Apr 21, 2017
FDA report date
May 31, 2017
Quantity
71,550 syringes
Recall type
Voluntary: Firm initiated
Recalling firm
Hospira Inc.

Original FDA data

Every field from FDA enforcement report D-0862-2017, exactly as published.

Show all FDA fields
City
Lake Forest
State
IL
Status
Ongoing
Country
United States
Event ID
77111
Address
600 N Field Dr
Code information
Lot 58382EV*, Exp 1OCT 2017, *lot may be followed by 01 or 02
Postal code
60045-4835
Report date
May 31, 2017
Product type
Drugs
Recall number
D-0862-2017
Classification
Class I
Recalling firm
Hospira Inc.
Product quantity
71,550 syringes
Reason for recall
Presence of Particulate Matter: human hair found within an internal sample syringe.
Voluntary / mandated
Voluntary: Firm initiated
Product description
Infant 25% DEXTROSE Injection, USP, 2.5 g (250 mg/mL), 10 mL Unit of Use Single-dose Syringe per carton, Rx only, Hospira Inc., Lake Forest, IL 60045, NDC 0409-1775-10
Distribution pattern
Nationwide in the USA and Puerto Rico
Recall initiation date
Apr 21, 2017
Initial firm notification
Press Release
Center classification date
May 24, 2017

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0862-2017, published May 31, 2017. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

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