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Class I: serious health riskTerminated

Hospira Morphine Sulfate Injection Recall

Morphine Sulfate Injection, USP, 4mg/mL, 1 mL fill in 2

Hospira Inc. · Lake Forest, IL

Risk level
Class I
Reported by FDA
Jul 25, 2012
Recall ID
D-1419-2012
Check your lot numberHow we source this data

Summary

Hospira recalled Morphine Sulfate Injection starting Apr 17, 2012. The FDA classified it as Class I (serious health risk) and published enforcement report D-1419-2012 on Jul 25, 2012. Reason: Superpotent; Cartridges labeled to contain 1 mL found to contain 2.2 mL. Status: Terminated.

Why it was recalled

Superpotent; Cartridges labeled to contain 1 mL found to contain 2.2 mL

Product description

Morphine Sulfate Injection, USP, 4mg/mL, 1 mL fill in 2.5 mL Carpuject Cartridge Unit with Luer Lock, packaged 10 Carpujects/carton, CII, Rx only, Hospira, Inc., Lake Forest, IL ---- NDC 0409-1258-30

Lot numbers, UPCs & expiration codes

Lot #10830LL, Exp. 1APR2013

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-1419-2012
Classification
Class I
Status
Terminated
Recall initiated
Apr 17, 2012
FDA report date
Jul 25, 2012
Quantity
212,370 cartidges
Recall type
Voluntary: Firm initiated
Recalling firm
Hospira Inc.

Original FDA data

Every field from FDA enforcement report D-1419-2012, exactly as published.

Show all FDA fields
City
Lake Forest
State
IL
Status
Terminated
Country
United States
Event ID
61624
Address
275 N Field Dr
Code information
Lot #10830LL, Exp. 1APR2013
Postal code
60045-2579
Report date
Jul 25, 2012
Product type
Drugs
Recall number
D-1419-2012
Classification
Class I
Recalling firm
Hospira Inc.
Product quantity
212,370 cartidges
Termination date
May 29, 2015
Reason for recall
Superpotent; Cartridges labeled to contain 1 mL found to contain 2.2 mL
Voluntary / mandated
Voluntary: Firm initiated
Product description
Morphine Sulfate Injection, USP, 4mg/mL, 1 mL fill in 2.5 mL Carpuject Cartridge Unit with Luer Lock, packaged 10 Carpujects/carton, CII, Rx only, Hospira, Inc., Lake Forest, IL ---- NDC 0409-1258-30
Distribution pattern
Nationwide
Recall initiation date
Apr 17, 2012
Initial firm notification
Press Release
Center classification date
Jul 15, 2012

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1419-2012, published Jul 25, 2012. 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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