Pharmaceutical company Hospira, Inc. announced April 24 it was recalling one lot of its injection products: Preservative-Free Bupivacaine HCl Injection with a USP of 0.5 percent. The recall came after the company received one complaint of visible orange and black particles free floating and embedded in a single-dose vial of the product. The particles were identified as iron oxide (better known as rust).
Before the recall, the company had not received any reports of illness or injury. The risks associated with the injection of particulate matter in patients include irritation at the injection site and possible allergic reaction to iron oxide. The lot of injection fluid was distributed between July 2014 and September 2014 and has been recalled for both human and veterinary use.
The current recall is a continuation of troubles for Hospira, and it is not the first time the company has had issues with particulate matter. In February 2015, Hospira recalled 60 lots of a painkiller in the U.S. and Singapore when particles of calcium-ketorolac crystals were found in the glass vials.
The Food and Drug Adminstration issued a warning letter in March 2015 reporting Hospira, which was just bought by Pfzer in February, was not in compliance with current good manufacturing practice regulations for finished pharmaceuticals at its Italy facility. At the time the letter was sent, Hospira had as yet “failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and sterilization processes.”
Hospira’s new India plant didn’t fare much better during FDA inspections, according to Fierce Pharma. After a routine 10-day inspection period that ended Feb. 25, 14 observations were given to the company by the FDA.