15-mg phenobarbital tablets recalled; pills are actually 30 mg each

15-mg phenobarbital tablets recalled; pills are actually 30 mg each

Labeling error leads to product withdrawal due to potential for patient harm.
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May 13, 2017
By dvm360.com staff

This article has been updated to reflect an expansion of the original recall.

C.O. Truxton Inc. has expanded a recall of phenobarbital that began with a label mixup affecting tablets labeled 15 mg. Those pills were discovered to be 30 mg, which could have led to overdosing of people and pets receiving the medication, according to a release from the U.S. Food and Drug Administration (FDA).

In late April the company voluntarily recalled lot 70952A, which contained at least one bottle of 30-mg phenobarbital tablets labeled as 15 mg, but several weeks later it expanded the recall to cover multiple lots of 15-mg, 30-mg, 60-mg and 100-mg phenobarbital tablets, as well as one lot of 50-mg amitriptylene tablets. C.O. Truxton has not received any complaints related to products included in the expanded recall but is exercising “an abundance of caution,” the FDA states.

The mislabeled product could expose people or pets to potential overdosing that can cause severe intoxication leading to cardiogenic shock, renal failure, coma or death, although the manufacturer has not received any reports of adverse events, the FDA states.

Phenobarbital is indicated for use as a sedative or anticonvulsant and is packaged in 1,000-count bottles. The 15-mg tablet is debossed with “West-ward 445” on one side and blank on the reverse side; the 30-mg tablet is debossed with “West-ward 450” on one side and scored on the reverse side. The product was distributed nationwide to physicians and veterinarians, the release states.

C.O. Truxton is notifying all customers on record who purchased affected product by U.S. mail, and the company is arranging for full-credit returns or replacements of recalled product. Anyone who possesses recalled product should stop using the product and return it to the place of purchase.

Veterinarians and pet owners with questions can contact C.O Truxton at (856) 933-2333.