February 17, 2017
The US Food and Drug Administration (FDA) issued a notification of a nationwide recall involving 67,946 30-count bottles of Aripiprazole Tablets, 2 mg.
Apotex Inc voluntarily recalled the atypical antipsychotic due to “Superpotent Drug: Product may not meet specifications throughout shelf life,” according to FDA Enforcement Report for the week of February 15, 2017.
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The recall was initiated on December 19, 2016. It is currently in progress.
The impacted tablets, which are used for the treatment of schizophrenia and manic and mixed episodes of bipolar I disorder, are from lot number MJ7746 (Exp 04/17).
The FDA labeled this as a Class III recall on February 9, 2017. Class III recalls include products that are “unlikely to cause any adverse health reaction, but that violate FDA labeling or manufacturing laws.”--Meredith Edwards White