Health Canada Recalls All Lots of Pms-Phenobarbital (60 mg)

Oversized Tablets Pose Risk for Overdose

Health Canada is warning consumers that all lots of the prescription drug pms - Phenobarbital tablets in the 60 milligram (mg) format (DIN 00178810) are being recalled because some oversized tablets were recently found on the Canadian market.

The oversized tablets were found to contain more Phenobarbital than the label indicates, exposing patients to the potential risk of accidental overdose. The Canadian distributor, Pharmascience Inc. of Montreal Quebec, has initiated a recall of all lots presently on the market.

Phenobarbital is widely used as an anticonvulsant for the treatment of seizure disorders, and it is also used to treat anxiety and sleep related disorders as it has sedative and hypnotic properties.

The oversized tablets may contain significantly more phenobarbital than the 60 mg indicated on the label. Symptoms of an overdose may include uncontrolled eye movements, lack of muscle coordination, impaired speech, extreme drowsiness, decreased breathing and heart rate and may begin within 1-2 hours after taking a Phenobarbital overdose. An overdose may be life threatening and can result in a coma and/or cardiac arrest.

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Published on Jun-26-09