Recall Enforment Report D-0468-2024

Recall Details

Multi event Drug Recall Enforcement Report Class III voluntary initiated by Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd., originally initiated on 04-09-2024 for the product Abilify (aripiprazole), 15 mg tablets, packaged in 30 count bottles, RX only, Otsuka America Pharmaceutical, Inc., NDC 59148-009-13 The product was recalled due to cross contamination with other products. The product was distributed nationwide and the recall is currently ongoing.

Recall Enforcement Reports

Recall Number Recall Initiation Date Report Date Recall Classification Quantity Product Description Recall Reason Status
D-0468-202404-09-202405-01-2024Class IIIAbilify (aripiprazole), 15 mg tablets, packaged in 30 count bottles, RX only, Otsuka America Pharmaceutical, Inc., NDC 59148-009-13Cross Contamination with Other ProductsOngoing
D-0467-202404-09-202405-01-2024Class IIIAbilify (aripiprazole), 10 mg tablets, packaged in a) 30 count bottles (NDC 59148-008-13) and b) 7 count blister packs (NDC 59148-008-95), RX only, Otsuka America Pharmaceutical, Inc.Cross Contamination with Other ProductsOngoing
D-0466-202404-09-202405-01-2024Class III108,192/30 count bottles or 7 count blister packsAbilify (aripiprazole), 5 mg tablets, packaged in 30 count bottles, RX only, Otsuka America Pharmaceutical, Inc., NDC 59148-007-13Cross Contamination with Other ProductsOngoing
D-0469-202404-09-202405-01-2024Class IIIAbilify (aripiprazole), 30 mg tablets, packaged in 30 count bottles, RX only, Otsuka America Pharmaceutical, Inc., NDC 59148-011-13Cross Contamination with Other ProductsOngoing

Recalled Products

NDC Proprietary Name Non-Proprietary Name Dosage Form Route Name Company Name Product Type
59148-006Abilify AripiprazoleTabletOralOtsuka America Pharmaceutical, Inc.Human Prescription Drug
59148-007Abilify AripiprazoleTabletOralOtsuka America Pharmaceutical, Inc.Human Prescription Drug
59148-008Abilify AripiprazoleTabletOralOtsuka America Pharmaceutical, Inc.Human Prescription Drug
59148-009Abilify AripiprazoleTabletOralOtsuka America Pharmaceutical, Inc.Human Prescription Drug
59148-010Abilify AripiprazoleTabletOralOtsuka America Pharmaceutical, Inc.Human Prescription Drug
59148-011Abilify AripiprazoleTabletOralOtsuka America Pharmaceutical, Inc.Human Prescription Drug