Morphine Sulfate Injection USP, 4 mg/mL (C-II), 1 mL fill in 2.5 mL Carpuject by Hospira, Inc Recalled as it May Contain More Than Intended Fill Volume causing Life-Threatening Consequences

Risk Manager and Pain Management healthcare personnel are informed by the FDA that Hospira, Inc, Morphine Sulfate Injection USP, 4 mg/mL (C-II), 1 mL fill in 2.5 mL Carpuject is recalled because it may contain more than the intended fill volume resulting in respiratory depression and low blood pressure.

Background of Morphine Sulfate Injection USP, 4 mg/mL (C-II), 1 mL fill in 2.5 mL Carpuject

Morphine Sulfate Injection USP, 4 mg/mL (C-II), 1 mL fill in 2.5 mL Carpuject, by Hospira, Inc, is a prefilled glass cartridge to be used with the Carpuject Syringe system.  The Carpuject syringe system consists of pre-filled cartridges that are loaded into a syringe holder to create a drug delivery system.

Morphine Sulfate Carpujects 4 mg/mL are packaged in Slim-Pak tamper detection packages with each box containing 10 Carpujects (NDC 0409-1258-30).

FDA Alert on Morphine Sulfate Injection USP, 4 mg/mL (C-II), 1 mL fill in 2.5 mL Carpuject

FDA’s reason for the recall is that Morphine Sulfate Injection USP, 4 mg/mL (C-II), 1 mL fill in 2.5 mL Carpuject, may contain more than the intended fill volume. In case of morphine overdose the consequences can be life-threatening including respiratory depression and low blood pressure.

The lot that is affected by this recall is 10830LL. This lot has an expiration date of April 1, 2013. It was distributed in January 2012, initially to wholesalers and a limited number of hospitals in Virginia, Texas, Ohio, Minnesota, Michigan, Indiana, Illinois, Hawaii, Colorado, and Arizona.

FDA Recommendation on Morphine Sulfate Injection USP, 4 mg/mL (C-II), 1 mL fill in 2.5 mL Carpuject

“Anyone with an existing inventory of affected product should stop use and distribution and quarantine the product immediately and call Stericycle at 1-888-912-7088 to arrange for the return of the product.”

Contacting the FDA to report cases with Morphine Sulfate Injection USP, 4 mg/mL (C-II), 1 mL fill in 2.5 mL Carpuject

In case of detection of adverse events or side effects related to the use of Morphine Sulfate Injection USP, 4 mg/mL (C-II), 1 mL fill in 2.5 mL Carpuject, 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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