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Recall Observatory FDA recall evidence

Drug product

METOPROLOL TARTRATE Tablet, 12.5 mg (1/2 of 25 mg), Rx only, Distributed by: AidaPak Service, LLC, NDC 57664050652

D-628-2014

July 02, 2013

Class II

Product summary

Firm
Aidapak Services, LLC
Event
Event 65707
Status
Terminated
Classification
Class II
Quantity
402 Tablets
Official record key
drug-enforcement:D-628-2014

Official wording

Reason: Labeling:Label Mixup; METOPROLOL TARTRATE Tablet, 12.5 mg (1/2 of 25 mg) may be potentially mislabeled as DOCUSATE SODIUM, Capsule, 250 mg, NDC 00904789159, Pedigree: AD68022_1, EXP: 5/28/2014; METOPROLOL TARTRATE, Tablet, 12.5 mg (1/2 of 25 mg), NDC 57664050652, Pedigree: AD68010_14, EXP: 5/28/2014.

Code information: METOPROLOL TARTRATE, Tablet, 12.5 mg (1/2 of 25 mg) has the following codes Pedigree: AD68010_14, EXP: 5/28/2014; Pedigree: AD68010_17, EXP: 5/28/2014.

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