Pfizer unit Hospira has recalled one lot of the anaesthetic made at its facility in Rocky Mount, North Carolina after particulate matter was found in a vial of the drug.
Hospira has reached “a major milestone” in its remediation efforts at its troubled Rocky Mount plant following a US FDA inspection which resulted in zero observations.
Hospira has agreed to pay $60m (€44m) to settle a lawsuit related to manufacturing and quality control deficiencies at its Rocky Mount facility, which is already subject to a $200m remediation programme.
The US FDA has upgraded Hospira’s troubled Rocky Mount, North Carolina plant to VAI (voluntary action indicated) status though its 2010 Warning Letter still stands.
Manufacturing problems and costs associated with a new device-focused strategy hurt in Q1, but Hospira says efforts to fix troubled Rocky Mount facility are still on track.
Hospira says bringing medical device manufacturing operations up to code will take 'a lot of work' after Lake Forest, Illinois plant is hit with US FDA Form 483.
Hospira hopes to ramp up output at its Rocky Mount facility in the second half of 2012 but warned it is “very difficult” to predict the remediation timeline.
