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Recall Observatory FDA recall evidence

Drug product

AMANTADINE HCL, Capsule, 100 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00781204801.

D-1003-2014

July 02, 2013

Class II

Product summary

Firm
Aidapak Services, LLC
Event
Event 65690
Status
Terminated
Classification
Class II
Quantity
499 Capsules
Official record key
drug-enforcement:D-1003-2014

Official wording

Reason: Labeling: Label Mixup: AMANTADINE HCL, Capsule, 100 mg may have potentially been mislabeled as one of the following drugs: ACARBOSE, Tablet, 25 mg, NDC 00054014025, Pedigree: W002725, EXP: 6/6/2014; clomiPRAMINE HCl, Capsule, 50 mg, NDC 51672401205, Pedigree: W002998, EXP: 6/11/2014; ASPIRIN EC DR, Tablet, 81 mg, NDC 49348098015, Pedigree: W003672, EXP: 2/28/2014; NIACIN TR, Capsule, 500 mg, N

Code information: AMANTADINE HCL, Capsule, 100 mg has the following codes: Pedigree: W002726, EXP: 6/6/2014; Pedigree: W002997, EXP: 6/11/2014; Pedigree: W003674, EXP: 6/25/2014; Pedigree: W003323, 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