Label Changes for:
Trobicin (Spectinomycin) for Injectable Suspension
Changes have been made to the WARNINGS sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – August 2012
- Removed]: Contains benzyl alcohol. Benzyl alcohol has been reported to be associated with a fatal "Gasping Syndrome" in premature infants and an increased incidence of neurologic and other complications.