Drug manufacturer Hospira is recalling 7 lots of propofol and 1 lot of lidocaine due to confirmed reports of metal particulates floating in the solutions and embedded in the glass vials containing them.
The affected lots of the company's propofol injectable emulsion, 1%, 200mg/20mL (10mg/mL), were distributed nationally between August and December 2013. The lot numbers are 29-614-DJ, 29-615-DJ, 29-616-DJ, 29-617-DJ, 29-628-DJ, 29-629-DJ and 29-630-DJ, each of which carries an expiration date of May 1, 2015, according to a press release posted on the U.S. Food and Drug Administration's web site.
The 1% lidocaine HCI injection, USP, 10mg/mL, 30mL single dose, preservative-free, was distributed nationwide in September and October of last year with the lot number 31-427-DK and an expiration date of July 1, 2015, says the FDA.
Hospira has sent distributors and customers a recall letter, and is recommending that facilities immediately stop using and quarantine any affected vials of the drugs. The company will be arranging returns for the product.
While the FDA has not received reports of any adverse events resulting from the contamination, it notes that particulates which pass through the catheter and are injected into the patient may cause local inflammation, phlebitis, allergic response, capillary occlusion and other complications.