Hospira Propofol has been recalled for a vial defect, the U.S. Food & Drug Administration (FDA) just announced. Hospira, Inc. describes itself as the world’s leading provider of injectable drugs and infusion technologies.
The nationwide recall involves three lots of Propofol Injectable Emulsion, 1%, 1g/100 mL, due to visible particles embedded in the glass at the user level. This may cause the potential for drug to come into contact with the embedded particles and the particles may become dislodged into the solution. Propofol Injectable Emulsion, 1%, 1 g / 100 mL (10 mg/mL) with NDC number 0409-4699-24, with the following lot and expiration dates are involved:
- Lot 07-893-DJ and Expiration Date 01JUL2013
- Lot 10-123-DJ and Expiration Date 01OCT2013
- Lot 10-125-DJ and Expiration Date 01OCT2013.
In the event particulate matter is injected into a patient, there exists the potential for patient injury requiring medical intervention. Risks 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 and has initiated an investigation to determine the root cause and develop corrective and preventative measures. Preliminary investigation results include identifying the root cause as a supplier glass defect. Hospira is working with its glass vial supplier to determine the cause of the defect.
The recalled Propofol 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 said it has advised its distributors and customers by letters and is arranging for return/replacement of all recalled products. Those with existing U.S. inventory should stop use and distribution, quarantine the product immediately, and call Stericycle, toll-free, at 1.888.410.7509, between 8:00 a.m. and 5:00 p.m. Eastern Daylight Time (EDT), Monday through Friday, to arrange for the product return. Hospira Customer Care can be reached, toll-free, at 1.877.976.7747, from 8:00 a.m. to 5:00 p.m., Central Daylight Time (CDT), Monday Friday, for product availability questions. Hospira Medical Communications can be reached, toll-free, at 1.800.615.0187 concerning medical inquiries, 24 hours daily, seven days a week.
Adverse reactions or quality problems 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.gove/MedWatch/getforms.htm; or toll-free Fax: 1.800.FDA.0178.
This is not the first time Hospira has issued a recall over defective products and not the first time it has recalled Propofol over particulate matter. Hospira expanded a March 2010, recall of its Propofol Injectable Emulsion 1% and Liposyn (Intravenous Fat Emulsion) products because some recalled containers might have contained particulate matter primarily made up of subvisible inert stainless steel particles.
Earlier this year, we wrote that Hospira recalled morphine injections because the syringes may be over-filled and, in 2010, Hospira recalled its Symbiq Infusion Systems One-Channel and Two-Channel Infusers, a recall deemed a Class I by the agency because of the potential for the device to fail to detect air in line at the end of an infusion, which could result in the delivery of air to the patient, which could lead to serious injury or death.