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Recall Observatory FDA recall evidence

Drug product

OLANZAPINE, Tablet 7.5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 60505311203

D-663-2014

July 02, 2013

Class II

Product summary

Firm
Aidapak Services, LLC
Event
Event 65707
Status
Terminated
Classification
Class II
Quantity
60 Tablets
Official record key
drug-enforcement:D-663-2014

Official wording

Reason: Labeling:Label Mixup; OLANZAPINE, Tablet 7.5 mg may be potentially mislabeled as NORTRIPTYLINE HCL, Capsule, 75 mg, NDC 00093081301, Pedigree: AD21790_73, EXP: 5/1/2014.

Code information: OLANZAPINE, Tablet, 7.5 mg has the following code Pedigree: AD21790_76, EXP: 5/1/2014.

Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    mislabeled