BETHESDA, MD 16 August 2012—A "supplier glass defect"—visible particles embedded in glass vials—has again prompted a recall of pharmaceuticals by Hospira Inc. This time the product is propofol injectable emulsion, 1 g in 100 mL.
FDA today circulated a press release in which Hospira announced it was recalling propofol injection lots 07-893-DJ, 10-123-DJ, and 10-125-DJ.
Anyone with vials from those lots should immediately quarantine the vials and call Stericycle Inc. at 888-410-7509, 8 a.m. to 5 p.m. EDT Monday through Friday, to arrange for their return. The vials had been distributed to wholesalers and direct customers from September 2011 through February 2012.
Questions about the availability of replacement vials should be directed to Hospira Customer Care at 877-976-7747, 8 a.m. to 5 p.m. CDT Monday through Friday.
FDA recently reinstituted the importation program with APP Pharmaceuticals Inc. to bring in Fresenius Propoven 1% from Europe.
An APP spokesman on Friday confirmed that the product, in 20-mL ampuls and 50- and 100-mL vials, is in the United States and available for delivery.
Hospira said it was working with its supplier of glass vials to determine the cause of the defect.
In late June, the company recalled 19 lots of carboplatin, cytarabine, paclitaxel, and methotrexate, all of which had been distributed November 2011 through May 2012. A press release dated July 13 said the company had initiated corrective and preventive actions regarding the defect in the glass vials.