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Recall Observatory FDA recall evidence

Drug product

METOPROLOL TARTRATE Tablet, 25 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 57664050652

D-629-2014

July 02, 2013

Class II

Product summary

Firm
Aidapak Services, LLC
Event
Event 65707
Status
Terminated
Classification
Class II
Quantity
300 Tablets
Official record key
drug-enforcement:D-629-2014

Official wording

Reason: Labeling:Label Mixup; METOPROLOL TARTRATE, Tablet, 25 mg may be potentially mislabeled as ASCORBIC ACID, Tablet, 250 mg, NDC 00904052260, Pedigree: W003826, EXP: 6/27/2014; amLODIPine BESYLATE, Tablet, 5 mg, NDC 00093716798, Pedigree: W002840, EXP: 6/7/2014.

Code information: METOPROLOL TARTRATE, Tablet, 25 mg has the following codes Pedigree: W003843, EXP: 6/27/2014; Pedigree: W002841, EXP: 6/7/2014.

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