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Recall Observatory FDA recall evidence

Drug product

Abilify (aripiprazole), 5 mg tablets, packaged in 30 count bottles, RX only, Otsuka America Pharmaceutical, Inc., NDC 59148-007-13

D-0466-2024

April 09, 2024

Class III

Product summary

Firm
Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd.
Event
Event 94382
Status
Ongoing
Classification
Class III
Quantity
108,192/30 count bottles or 7 count blister packs
Official record key
drug-enforcement:D-0466-2024

Official wording

Reason: Cross Contamination with Other Products

Code information: Lot # AKS00623A, Exp 01/31/2026; AKS00322A, Exp 02/28/2025

Distribution pattern: USA nationwide.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Cross Contamination with Other Products