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Recall Observatory FDA recall evidence

Drug product

ASCORBIC ACID, CHEW Tablet, 500 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904052660.

D-1021-2014

July 02, 2013

Class II

Product summary

Firm
Aidapak Services, LLC
Event
Event 65690
Status
Terminated
Classification
Class II
Quantity
100 CHEW Tablets
Official record key
drug-enforcement:D-1021-2014

Official wording

Reason: Labeling: Label Mixup: ASCORBIC ACID, CHEW Tablet, 500 mg may have potentially been mislabeled as the following drug: PHENOL, LOZENGE, 29 mg, NDC 00068021918, Pedigree: AD60428_4, EXP: 5/22/2014.

Code information: ASCORBIC ACID, CHEW Tablet, 500 mg has the following codes: Pedigree: AD60240_54, EXP: 5/22/2014.

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