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Recall Observatory FDA recall evidence

Drug product

METOPROLOL TARTRATE, Tablet, 50 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00093073301.

D-825-2014

July 02, 2013

Class II

Product summary

Firm
Aidapak Services, LLC
Event
Event 65690
Status
Terminated
Classification
Class II
Quantity
300 Tablets
Official record key
drug-enforcement:D-825-2014

Official wording

Reason: Labeling: Label Mixup: METOPROLOL TARTRATE, Tablet, 50 mg may have potentially been mislabeled as one of the following drugs: METOPROLOL TARTRATE, Tablet, 25 mg, NDC 57664050652, Pedigree: W003843, EXP: 6/27/2014; ATORVASTATIN CALCIUM, Tablet, 20 mg, NDC 60505257909, Pedigree: W003846, EXP: 6/27/2014; OXYBUTYNIN CHLORIDE, Tablet, 5 mg, NDC 00603497521, Pedigree: W003898, EXP: 6/27/2014.

Code information: METOPROLOL TARTRATE, Tablet, 50 mg has the following codes: Pedigree: W003844, EXP: 6/27/2014; Pedigree: W003848, EXP: 6/27/2014; Pedigree: W003900, EXP: 6/27/2014.

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