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The company is expanding their April 2017 voluntary recall of phenobarbital tablets.
On May 8, 2017, C.O. Truxton announced it was expanding its voluntary recall of phenobarbital tablets to all products repackaged with a Truxton Incorporated label out of caution. The original recall of phenobarbital tablets, issued April 21, 2017, was due to mislabeled product. The new recall extends to amitriptyline tablets, USP 52 mg.
An overdose of amitriptyline, which is used as a tricyclic antidepressant, could lead to uneven heartbeats, extreme drowsiness, confusion, agitation, vomiting, hallucinations, hot or cold sensations, muscle stiffness, seizures (convulsions), or fainting in humans. The company has not received any reports of adverse events associated with the recalled products as of May 8, 2017.
Source: FDA