SYNTEX TORADOL IM SYRINGE FAILURE REPORTS ARE SUBJECT OF FDA WARNING

Executive Summary

SYNTEX TORADOL IM SYRINGE FAILURE REPORTS ARE SUBJECT OF FDA WARNING letter sent to the company March 4. During an inspection of Syntex' Palo Alto facilities in October and November, the warning letter states, an FDA inspector "discussed with your staff complaints FDA had received from health care professionals concerning defects in the delivery system" for Toradol (ketorolac) injectable. "Chief among the complaints was the failure of the prefilled syringe plunger to fully depress, resulting in only a portion of the drug dosage being delivered to the patient," the letter states.