Hospira Announces a Nationwide Voluntary Recall of One Lot of Morphine Sulfate Injection, USP 4 MG/ML, (C-II) 1 ML Fill in 2.5 ML Carpuject
From Targeted News Service (April 17, 2012)
Hospira Announces a Nationwide Voluntary Recall of One Lot of Morphine Sulfate Injection, USP 4 MG/ML, (C-II) 1 ML Fill in 2.5 ML Carpuject, That May Contain More than the Intended Fill Volume
WASHINGTON, April 17 -- The U.S. Department of Health & Human Services' Food & Drug Administration issued the following recall notice:
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(TM) 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.
For medical inquiries, please contact Hospira Medical Communications at 1-800-615-0187. This phone number is available 24 hours a day, seven days a week.
Any adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Events Program either online, buy regular mail or by by fax.
* Online: www.fda.gov/medwatch/report.htm
* Regular Mail: use postage-paid, pre-addressed Form FDA3500 available at www.fda.gove/MedWatch/getforms.htm
* Fax: 1-800-FDA-0178
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration (FDA).
Hospira, Inc. is the world's leading provider of injectable drugs and infusion technologies. Through its broad, integrated portfolio, Hospira is uniquely positioned to Advance Wellness by improving patient and caregiver safety while reducing healthcare costs. The company is headquartered in Lake Forest, Ill., and has approximately 15,000 employees. Learn more at www.hospira.com .
TNS MT93 120418-3843327 61MarlizTagarum
Posted: April 2012
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