Pfizer has largely turned a corner on its sterile injectables business after snapping up Hospira in 2015. Still, a labeling snafu has landed the company's injectables subsidiary back on the FDA's recall list.
Pfizer's Hospira is recalling one lot each of the injectable hospital anesthetics bupivacaine hydrochloride (HCL) and lidocaine HCL after an investigation into a confirmed customer report revealed that a portion of each lot was mislabeled as the other product.
Drug labelling mix-ups can have serious safety implications, and for hospital drugs especially so. Hospira, for its part, warned of "moderate to high severity" safety risks in patients who received the wrong product.
If a patient were to receive 1% lidocaine instead of 0.5% bupivacaine, they could be underdosed, potentially leading to subpar pain management and failure of surgical anesthesia, Hospira said.
On the flip side, a patient who receives an affected bupivacaine dose in place of lidocaine could overdose, which could cause seizures, low oxygen and-or elevated carbon dioxide levels in the blood, and more. A bupivacaine overdose could also lead to cardiovascular issues like irregular heartbeat, cardiac arrest and cardiac flatline, Hospira said.
The products were shipped out across the U.S., Puerto Rico and Guam between December 29, 2020 and April 15, 2021, Hospira said in a notice posted on the FDA's website. The bupivacaine lot was due to expire in July 2022, while the lidocaine batch was meant to be good until August 2022.
Pfizer's sterile injectables business has grappled with quality issues since the pharma giant bought out Hospira in 2015. Since then, Pfizer has made "substantial investments to modernize its sterile injectables network, which includes installing new lines and equipment, hiring additional colleagues, and establishing redundant sources of supply, among other initiatives,” a Pfizer spokesman told Fierce Pharma via email last month.
On that front, Pfizer is also building a new $450 million sterile injectables facility in Portage, Michigan. Dubbed its Modular Aseptic Processing (MAP) facility, Pfizer is trumpeting the injectables plant as one of the most “technically advanced” in the world.