Hospira, Inc. (NYSE: HSP), announced today it is
initiating a voluntary user level recall of one lot of Morphine Sulfate
Injection USP, 4 mg/mL (C-II), 1 mL fill in 2.5 mL Carpuject, NDC
0409-1258-30, due to a customer report of two Carpujects syringes
containing more than the 1 mL labeled fill volume.
Opioid pain
medications such as morphine have life-threatening consequences if
overdosed. Those consequences can include respiratory depression
(slowed breathing or suspension of breathing), and low blood pressure.
The
affected product is a prefilled glass cartridge for use with the
Carpuject™ Syringe system. The affected lot number is 10830LL. The
expiration date is April 1, 2013. Morphine Sulfate Carpujects 4 mg/mL
are packaged in Slim-Pak® tamper detection packages with each box
containing 10 Carpujects (NDC 0409-1258-30).
The affected lot
was distributed in January 2012. It was initially distributed to
wholesalers and a limited number of hospitals in Arizona, Colorado,
Hawaii, Illinois, Indiana, Michigan, Minnesota, Ohio, Texas and
Virginia.
Hospira has not received any reports of adverse
events related to this issue for this lot. This is believed to be an
isolated event, and Hospira has initiated an investigation to determine
the root cause and preventive actions. Consumers should contact their
physician or healthcare provider if they have experianced any problems
that may be related to taking or using this product.
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.
Replacement product from other lots is available. Customers can send
their DEA 222 form to Hospira, 1635 Stone Ridge Drive, Stone
Mountain, GA 30083 to order replacement product.
http://www.fda.gov/Safety/Recalls/ucm300813.htm
