Teva Pharmaceuticals USA Inc. is recalling one lot of the antipsychotic drug Paliperidone Extended-Release Tablets distributed under the Actives Pharma Inc. label, because the tablets may be sub-potent, the Food and Drug Administration (FDA) announced in a recall communication.
The recall involves Lot # 1160682A with the expiration date 6/2018 in 3-milligram strength in 90-count bottles. The bottles are also stamped with the NDC# 0591-3693-19 and were distributed nationwide from Dec. 12, 2016, through March 16, 2017. The recall was initiated because a batch of pills failed test results for dissolution. As a result, Teva cannot exclude the potential for additional tablets to be below specification.
Paliperidone Extended Release Tablets are indicated for the treatment of schizophrenia and schizoaffective disorders. Tablets that have failed dissolution could result in less drug being absorbed. If two or more consecutive dosing regimens occur, there could be a failure to maintain therapeutic levels in the patient, which could reduce the effectiveness of treatment for a patient’s mental and/or mood symptoms, and result in issues such as suicidal thoughts and behavior, self-injurious behavior, mental hospitalizations, assaults, aggressive behavior, as well as vocal and motor tics.
Teva says that based on its investigation, the risk of a patient taking two or more consecutive sub-potent doses is low. The company has also received no adverse event reports to date.
Teva has notified its distributors of the recall and advised them to notify their customers who may have the recalled product. Consumers with questions regarding this recall can contact Teva at 888-838-2872, option 3, then option 4, or email email@example.com. Consumers who have experienced any problems that may be related to this recall should contact their doctor.
Any adverse events related to this recalled drug should be reported to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.
Source: FDA Recalls