Hospira, Inc. – now a Pfizer company – issued the nationwide recall of three lots of its 100mg/20mg vial, and one lot of Labetalol Hydrochloride Injection, USP, Novaplus, indicated to control blood pressure in severe hypertension.
The firm said cracks on the rim surface of vials – which are covered by a stopper and crimp seal – for these lots could result in a lack of sterility assurance.
“Hospira, Inc. completed an assessment, which concluded that although there have been no reports of relevant adverse events associated with this issue for these lots, the use of or exposure to the impacted product may be associated with adverse events such as fever, chills, sepsis or invasive systemic infections in patient,” a spokesperson told us.
“The potential risk to a patient or healthcare professional arising from the issue is considered to be medium,” she added.
Labetalol Hydrochloride is an adrenergic receptor blocking agent which can be administered by repeated intravenous injections or by slow IV infusion to control blood pressure in severe hypertension.
The drug product was distributed to wholesalers, retailers and hospitals in the US and Puerto Rico between April and August last year.
Form 483 repeat observations
The affected lots were manufactured at the McPherson, Kansas site, one of a number Pfizer added to its network when it acquired Hospira for $17bn in 2015
The fill and finish plant – part of Pfizer’s contract manufacturing business CentreOne – received a US Food and Drug Administration (FDA) warning letter in February 2017.
The GMP issues cited in the letter prompted rejection of the firm’s biosimilar version of Amgen’s anaemia drug Epogen (epoetin alfa), and delayed approval of Sandoz/Momenta’s generic version of Teva’s Copaxone (glatiramer acetate injection).
Last month, Pfizer announced the FDA had upgraded the status of the facility to Voluntary Action Indicated (VAI), following an inspection last October. But the inspection had also resulted in a Form 483 with 10 observations which has recently been released.
The FDA found problems highlighted in the February warning continued to plague the facility, including failures in investigating unexplained discrepancies among batches.
Specifically, the FDA said there was a lack of action and testing on batches of the drug Marcaine (bupivacaine HCI with dextrose), after the firm received numerous complaints regarding the lack of effect.
Other repeat observations included using manufacturing equipment for operations not appropriate for its purpose; failures in examining visually at least once a year reserve samples from representative sample lots; failing to submit an NDA-field alert report within three days after receiving information concerning failure of distributed drug batches; and failing to include conclusions and follow-ups in written batch failure records.