The batch, lot number 311756, was distributed in the US between June 11 and June 16 this year. In a press statement Barr said that it had initiated the recall because the oversized tablets can cause a variety of clinically-significant adverse reactions.

These reactions include palpitations, tachycardia, hypertension, headache, tremor, tic, dyskinesia, dizziness, blurred vision, sweating, insomnia, agitation, euphoria, mania, anxiety, restlessness, nausea, diarrhea, constipation, dry mouth, and decreased appetite.

Barr, which was bought by Israeli generics firm Teva Pharmaceutical Industries late last year, did not respond to in-PharmaTechnologist’s request for additional information.