A production line for J&J unit Janssen's antipsychotic drug Invega Sustenna is back in operation following an investigation into cracked syringes. A 70,000-dose recall is under way.
Users are unlikely to have seen the cracks on the syringe barrel because they were covered by labels. The defect was found during routine testing at the Belgium manufacturing site. Janssen suspects that stress during label application caused the cracking.
Only 234-mg dose syringes have shown the cracking. Distribution began last March, and the recall notice was sent to distributors, pharmacists and healthcare providers in the U.S., Australia, Canada and South Korea.