Recall -- Firm Press Release
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Hospira Announces A Nationwide Voluntary Recall Of One
Lot Of Hydromorphone Hydrochloride Injection 2 MG/ML, (C-II)
1 ML Fill In 2.5 ML Carpuject, That May Contain More Than The Intended Fill Volume
FOR IMMEDIATE RELEASE - August 15, 2012 - LAKE FOREST, Ill., - Hospira, Inc. (NYSE: HSP), announced today it is initiating a voluntary user level recall of one lot of Hydromorphone Injection, USP, 2 mg/mL (C-II), 1 mL fill in 2.5 mL Carpuject™, NDC 0409-1312-30 , due to a reported complaint of a single Carpuject containing more than the 1 mL labeled fill volume.
Opioid pain medications such as Hydromorphone have life-threatening consequences if overdosed. Those consequences can include respiratory depression (slowed breathing or suspension of breathing), low blood pressure and reduced heart rate including circulatory collapse.
The affected product is a prefilled glass cartridge for use with the Carpuject Syringe system. The affected lot number is 12720LL. The expiration date is December 1, 2013.
The affected lot was distributed in March – May 2012.
Hospira had notified healthcare professionals in May 2012 regarding the potential for overfill in the pre-filled Carpuject™ Syringe System, as some syringes may contain more medication than is stated on the label. This specific lot was identified in that communication, and was manufactured prior to the implementation of those preventive actions. Hospira is undertaking this recall in consideration of the potential for safety issues if the product is administered to patients.
Hospira has not received any reports of adverse events related to this issue for this lot. Hospira completed an investigation to determine the root cause and has put in place measures to prevent recurrence.
Anyone with an existing inventory should stop use and distribution, quarantine the product immediately, and call Stericycle at 1-866-873-0312 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 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.