Teva Pharmaceuticals Recalls Paliperidone

The company has extended its voluntarily recall of one lot of paliperidone extended-release tablets to the consumer level due to dissolution test failure.

Teva Pharmaceuticals announced on June 15, 2017 that it is extending its May 2017 voluntary recall of one lot of paliperidone extended-release tablets, 3-mg, 90-count bottles distributed under the Actavis Pharma Inc. label to the consumer/user level. The recall is due to failing dissolution tests.

Paliperidone is used to treat schizophrenia and schizoaffective disorders. According to Teva, taking paliperidone that has failed dissolution could result in decreased drug absorption, and a failure to maintain therapeutic levels could occur with two or more consecutive doses of the affected product. This decrease in levels could affect a patient’s mental and/or mood symptoms. The company, however, says the chance of taking two or more consecutive doses of the affected product is low.

The company is recommending the discontinued use and distribution of existing inventory. Adverse events may be reported to FDA at www.fda.gov/medwatch/report.htm.

Source: FDA