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Recall Observatory FDA recall evidence

Drug product

NEOMYCIN SULFATE Tablet, 500 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 51991073801

D-607-2014

July 02, 2013

Class II

Product summary

Firm
Aidapak Services, LLC
Event
Event 65707
Status
Terminated
Classification
Class II
Quantity
100 Tablets
Official record key
drug-enforcement:D-607-2014

Official wording

Reason: Labeling: Label Mixup; NEOMYCIN SULFATE, Tablet, 500 mg may be potentially mislabeled as IMIPRAMINE HCL, Tablet, 25 mg, NDC 00781176401, Pedigree: AD49448_10, EXP: 5/17/2014.

Code information: NEOMYCIN SULFATE, Tablet, 500 mg has the following code Pedigree: AD49448_17, EXP: 5/17/2014.

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