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Recall Observatory FDA recall evidence

Drug product

MIRTAZAPINE Tablet, 7.5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 59762141509

D-646-2014

July 02, 2013

Class II

Product summary

Firm
Aidapak Services, LLC
Event
Event 65707
Status
Terminated
Classification
Class II
Quantity
90 Tablets
Official record key
drug-enforcement:D-646-2014

Official wording

Reason: Labeling:Label Mixup; MIRTAZAPINE Tablet, 7.5 mg may be potentially mislabeled as ISONIAZID, Tablet, 300 mg, NDC 00555007102, Pedigree: W003691, EXP: 6/26/2014.

Code information: MIRTAZAPINE, Tablet, 7.5 mg has the following code Pedigree: W003693, EXP: 4/30/2014.

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