Hospira Announces A Nationwide Recall Of Three Lots Of Propofol Due To Glass Vial Defect
Date of Recall
2012-08-16Recall Details
- August 14, 2012 - Hospira, Inc. (NYSE: HSP), the world's leading provider of injectable drugs and infusion technologies, today announced a nationwide recall of three lots of Propofol Injectable Emulsion, 1%, 1g/100 mL, due to visible particles embedded in the glass to the user level. There may be potential for product to come into contact with the embedded particles and the particles may become dislodged into the solution. In the event in which particulate matter could be injected into a patient, there may be the potential for patient injury where medical intervention may be required. Risks associated with this defect could include tissue necrosis in one or more organs that could result in stroke, myocardial infarction, respiratory failure, and loss of renal and hepatic function.Hospira has not received any reports of adverse events related to these lots. Hospira has initiated an investigation to determine root cause and corrective and preventive measures. The investigation has preliminarily identified the root cause as a supplier glass defect. Hospira is working with its glass vial supplier to determine the cause of the defect.
The product is packaged in vials and indicated for the induction or maintenance of anesthesia in surgical patients or to initiate sleep in intensive care units. The affected lots were distributed nationwide to wholesalers and direct customers from September 2011 through February 2012. Hospira has issued a recall letter to U.S. customers voluntarily recalling the following lots:
|
Product |
NDC Number |
Lot* |
Expiration Date |
|
Propofol Injectable Emulsion, 1%, |
0409-4699-24 |
07-893-DJ |
01JUL2013 |
|
10-123-DJ |
01OCT2013 |
||
|
10-125-DJ |
01OCT2013 |
This recall is being conducted as a precautionary measure. The company is notifying its distributors and customers by letters and is arranging for return/replacement etc. of all recalled products. Anyone with an existing inventory in the United States should stop use and distribution, quarantine the product immediately and call Stericycle at 1-888-410-7509, between the hours of 8 a.m. to 5 p.m. EDT, Monday through Friday, to arrange for the return of the product. Customers can call Hospira Customer Care at 1-877-976-7747, between the hours of 8 a.m. to 5 p.m. CDT, Monday through Friday, to inquire about product availability.
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 these products may be reported to the FDA's MedWatch Adverse Events Program either online, by 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.gov/MedWatch/getforms.htm
- Fax: 1-800-FDA-0178
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
About Hospira
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 .
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