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Recall Observatory FDA recall evidence

Drug product

ESCITALOPRAM, Tablet, 5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00093585001.

D-839-2014

July 02, 2013

Class II

Product summary

Firm
Aidapak Services, LLC
Event
Event 65690
Status
Terminated
Classification
Class II
Quantity
100 Tablets
Official record key
drug-enforcement:D-839-2014

Official wording

Reason: Labeling: Label Mixup: ESCITALOPRAM, Tablet, 5 mgmay have potentially been mislabeled as the following drug: SODIUM CHLORIDE, Tablet, 1 gm, NDC 00223176001, Pedigree: W003707, EXP: 6/25/2014.

Code information: ESCITALOPRAM, Tablet, 5 mg has the following codes: Pedigree: W003733, EXP: 6/26/2014.

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