February 23, 2018
American Health Packaging is recalling 10-mg aripiprazole tablets, USP, in 100-tablet unit-dose blister packs (NDC 60687-179-11; UPC 003 60687 179 11 7) because the drug failed to meet dissolution specifications during testing, according to the February 21, 2018, US Food and Drug Administration (FDA) Enforcement Report.
The recall affects 270 cartons (NDC 60687-179-01) from lot 174096, which has an expiration date of May 31, 2019. The tablets were distributed across the United States.
American Health Packaging voluntarily initiated the recall January 19, 2018 as a sub-recall of the manufacturer’s recall. At press time, the FDA had not announced a recall classification.
Available with a prescription, aripiprazole is an atypical antipsychotic drug that treats certain mental health disorders including bipolar disorder, schizophrenia, and irritability associated with autism.
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