C.O. Truxton Recalls Amitriptyline HCL and Phenobarbital Tablets Over Potential Label Mix-Up
C.O. Truxton expanded an April 21 recall, as a precaution to include Amitriptyline HCL tablets, USP 50mg and phenobarbital tablets, USP 15mg, 30mg, 60mg, 100mg.
The company issued the initial recall when a labeling error indicating an incorrect dosage. The expanded recall, to include all products repackaged into a Truxton Incorporated label, was made out of “an abundance of caution,” the company said.
An overdose of phenobarbital could cause severe intoxication which may lead to cardiogenic shock, renal failure, coma, or death in humans.
C.O. Truxton has not received any reports of adverse events related to the recall.