Antipsychotic Sample Kits Recalled

Mislabeled physician sample kits containing Abilify and Abilify Maintena are being recalled by Otsuka Pharmaceutical Development & Commercialization Inc. According to the October 10, 2018, US Food and Drug Administration (FDA) Enforcement Report, the “[p]roduct name is misspelled, storage instructions are missing, and contents of kits may be incorrectly labeled on the outer packaging of the copackaged kit.”

The recall includes 17,325 kits of Abilify (aripiprazole)/Abilify Maintena (aripiprazole) 400 mg for extended-release injectable suspension. Each kit contains two packs of Abilify tablets 10 mg (14-day supply) plus one Abilify Maintena prefilled dual-chamber syringe. The recalled kits are from lots 7F92YUD3H1A/AIS1017B and 7F92YUD3H1A/AIS1017C (Exp. 6/30/20).

Also recalled are 4738 kits of Abilify (aripiprazole)/Abilify Maintena (aripiprazole) 400 mg for extended release-injectable suspension. Each kit contains two packs Abilify tablets 10 mg (14-day supply) plus 1 Abilify Maintena vial kit. The kits are from lots 7F92YUD3H1A/ACS1616B (7/31/19) and F92YUD3H1A/ACS0118C (6/30/20).

The kits were distributed throughout the United States.

Otsuka Pharmaceutical voluntarily initiated the recall September 17, 2018. At press time, the FDA had not yet issued a classification for the recall.

Abilify and Abilify Maintena are prescription antipsychotic medications used in the treatment of people with schizophrenia, bipolar disorder, depression, Tourette syndrome, and autism.

—Jolynn Tumolo

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