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Recall Observatory FDA recall evidence

Drug product

ZINC SULFATE, Capsule, 220 mg (50 mg Elem Zn), Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904533260

D-479-2014

July 02, 2013

Class II

Product summary

Firm
Aidapak Services, LLC
Event
Event 65707
Status
Terminated
Classification
Class II
Quantity
99 Capsules
Official record key
drug-enforcement:D-479-2014

Official wording

Reason: Labeling: Label Mixup; ZINC SULFATE, Capsule, 220 mg (50 mg Elem Zn) may be potentially mislabeled as PHOSPHORUS, Tablet, 250 mg, NDC 64980010401, Pedigree: AD56916_1, EXP: 5/21/2014.

Code information: ZINC SULFATE, Capsule, 220 mg (50 mg Elem Zn) has the following code Pedigree: AD57624_1, EXP: 5/9/2014.

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