Recalls

Manufacturing error leads to recall of generic version of Abilify

fda logo Manufacturing error leads to recall of generic version of Abilify Nearly 68,000 bottles of a generic version of the antipsychotic medication Abilify are being recalled because of a manufacturing defect that rendered the tablets superpotent and likely unable to meet specifications throughout the product’s shelf life. The recall is listed as a Class III, and not considered to cause any serious adverse events.

The recall is being initiated by Apotex Inc., and includes lot number MJ7746 with the expiration date of Apr. 4, 2017. The medication was distributed nationwide.

Abilify was initially approved in 2002 as a treatment for schizophrenia. The indication of Abilify has since been expanded to include an add-on treatment for adults with depression, for the treatment of adults and children with bipolar disorder, for adults and adolescents with schizophrenia, and for children ages 6 to 17 with irritability with autism.

Any adverse events related to the recall of generic Abilify should be reported to the Food and Drug Administration (FDA) MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.

In July 2016, the FDA warned that Abilify and other antipsychotic drugs containing the active ingredient aripiprazole could cause patients to suffer compulsive or uncontrollable urges to gamble, binge eat, shop, and have sex. This has prompted a number of against Abilify makers by people who suffered after taking the antipsychotic.

Sources:
FDA Enforcement Report
FDA Safety Communication