Hospira Carpuject Pre-filled Cartridges may be overfilled leading to overdose

Healthcare professionals and risk managers are warned by the FDA of a potential overdose from some Carpuject pre-filled cartridges by Hospira, Inc. as they might be overfilled.

Background of Carpuject Pre-filled Cartridges

The Carpuject pre-filled cartidges, manufactured by Hospira Inc., are pre-filled glass cartridges for use with the Carpuject Syringe system..

FDA Alert on Hospira Carpuject Pre-filled Cartridges

Hospira, Inc. received complaints from healthcare providers on the ocurrence of overfilled Carpuject pre-filled cartridges containing morphine and hydromorphone and informed the FDA. The Hospira Carpuject pre-filled cartridges might be overfilled by at least twice the expected amount leading to a potential overdose.

Further inspection of retained product by Hospira resulted to the detection of additional overfilled Carpuject pre-filled cartridges.  The risk for overfilled Carpuject pre-filled cartridges might affect as many as 280 lots of the following 15 different Carpuject pre-filled cartridge products:

• Demerol (meperidine HCl) Injection, USP
• Diazepam Injection, USP
• Fentanyl Citrate Injection, USP
• Heparin Lock Flush Solution, USP
• Heparin Sodium Injection, USP
• HYDROmorphone HCl Injection, USP
• Ketorolac Tromethamine Injection, USP
• Labetalol Hydrochloride Injection, USP
• Lorazepam Injection, USP
• Metoprolol Tartrate Injection, USP
• Midazolam Injection, USP
• Morphine Sulfate Injection, USP
• Naloxone Hydrochloride Injection, USP
• Ondansetron Injection, USP
• Sodium Chloride Injection, USP

FDA Recommendation on Hospira Carpuject Pre-filled Cartridges

“FDA is advising healthcare providers to follow the instructions provided with the medication and visually inspect and confirm that the Carpuject pre-filled cartridge contains the labeled fill volume before dispensing and again before administering to patients.

If a Carpuject pre-filled cartridge contains a greater volume of medication than described by the label, healthcare providers should not use the Carpuject pre-filled cartridge and should return it to Hospira.

FDA is still evaluating whether additional steps are necessary”.

Contacting the FDA to report cases with Hospira Carpuject Pre-filled Cartridges

In case of detection of overfilled Carpuject pre-filled cartridges, healthcare professionals and patients should report it to the FDA’s MedWatch Safety Information and Adverse Event Reporting program through any of the following ways:

The report can be completed and submitted Online at: www.fda.gov/MedWatch/report.htm

The form can be downloaded or requested by calling 1-800-332-1088, then completed and returned on the address indicated on the form

The completed form can be faxed to:  1-800-FDA-0178

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