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Recall Observatory FDA recall evidence

Drug product

CALCIUM CITRATE, Tablet, 200 mg Elemental Calcium, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904506260

D-470-2014

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-470-2014

Official wording

Reason: Labeling: Label Mixup; CALCIUM CITRATE, Tablet, 200 mg Elemental Calcium may be potentially mislabeled as TRIAMTERENE/HCTZ, Tablet, 37.5 mg/25 mg, NDC 00378135201, Pedigree: AD28333_4, EXP: 5/6/2014.

Code information: CALCIUM CITRATE, Tablet, 200 mg Elemental Calcium has the following code Pedigree: AD28333_1, EXP: 5/8/2014.

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