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Recall Observatory FDA recall evidence

Drug product

hydrOXYzine PAMOATE, Capsule, 100 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00555032402.

D-951-2014

July 02, 2013

Class II

Product summary

Firm
Aidapak Services, LLC
Event
Event 65690
Status
Terminated
Classification
Class II
Quantity
800 Capsules
Official record key
drug-enforcement:D-951-2014

Official wording

Reason: Labeling: Label Mixup: hydrOXYzine PAMOATE, Capsule, 100 mg may have potentially been mislabeled as one of the following drugs: CALCIUM CITRATE, Tablet, 950 mg (200 mg Elemental Calcium), NDC 00904506260, AD46257_43, EXP: 5/15/2014; guaiFENesin ER, Tablet, 600 mg, NDC 45802049878, Pedigree: W002734, EXP: 6/6/2014; guaiFENesin ER, Tablet, 600 mg, NDC 45802049878, Pedigree: W003689, EXP: 6/26/20

Code information: hydrOXYzine PAMOATE, Capsule, 100 mg has the following codes: Pedigree: AD46265_28, EXP: 5/15/2014; Pedigree: W002735, EXP: 6/6/2014; Pedigree: W003690, EXP: 6/26/2014; Pedigree: AD21790_61, EXP: 5/1/2014; Pedigree: AD60272_67, EXP: 5/22/2014; Pedigree: W003008, EXP: 6/11/2014; Pedigree: W003332, EXP: 6/18/2014.

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