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Class II: temporary or reversible health riskTerminated

Hospira Preservative-Free MORPHINE Sulfate Injection Recall

Preservative-Free MORPHINE Sulfate Injection, USP, 10 mg/10 mL (1 mg/mL) 10 mL vial, Rx…

Hospira Inc. · Lake Forest, IL

Risk level
Class II
Reported by FDA
May 8, 2013
Recall ID
D-308-2013
Check your lot numberHow we source this data

Summary

Hospira recalled Preservative-Free MORPHINE Sulfate Injection starting Aug 28, 2012. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-308-2013 on May 8, 2013. Reason: Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial. Status: Terminated.

Why it was recalled

Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial

Product description

Preservative-Free MORPHINE Sulfate Injection, USP, 10 mg/10 mL (1 mg/mL) 10 mL vial, Rx only, HOSPIRA, INC, LAKE FOREST, IL 60045 USA NDC 0409-3815-12

Lot numbers, UPCs & expiration codes

Lot 15-065-DK, Exp 1SEP2013

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-308-2013
Classification
Class II
Status
Terminated
Recall initiated
Aug 28, 2012
FDA report date
May 8, 2013
Quantity
26,100 vials
Recall type
Voluntary: Firm initiated
Recalling firm
Hospira Inc.

Original FDA data

Every field from FDA enforcement report D-308-2013, exactly as published.

Show all FDA fields
City
Lake Forest
State
IL
Status
Terminated
Country
United States
Event ID
64720
Address
275 N Field Dr
Code information
Lot 15-065-DK, Exp 1SEP2013
Postal code
60045-2579
Report date
May 8, 2013
Product type
Drugs
Recall number
D-308-2013
Classification
Class II
Recalling firm
Hospira Inc.
Product quantity
26,100 vials
Termination date
Sep 18, 2014
Reason for recall
Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial
Voluntary / mandated
Voluntary: Firm initiated
Product description
Preservative-Free MORPHINE Sulfate Injection, USP, 10 mg/10 mL (1 mg/mL) 10 mL vial, Rx only, HOSPIRA, INC, LAKE FOREST, IL 60045 USA NDC 0409-3815-12
Distribution pattern
Nationwide and Puerto Rico
Recall initiation date
Aug 28, 2012
Initial firm notification
Letter
Center classification date
May 1, 2013

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-308-2013, published May 8, 2013. View the source record (openFDA) · FDA enforcement reports

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

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