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Recall Observatory FDA recall evidence

Drug product

DESLORATADINE, Tablet, 5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00085126401.

D-821-2014

July 02, 2013

Class II

Product summary

Firm
Aidapak Services, LLC
Event
Event 65690
Status
Terminated
Classification
Class II
Quantity
101 Tablets
Official record key
drug-enforcement:D-821-2014

Official wording

Reason: Labeling: Label Mixup: DESLORATADINE, Tablet, 5 mg may have potentially been mislabeled as the following drug: ASCORBIC ACID, Tablet, 250 mg, NDC 00904052260, Pedigree: AD30180_28, EXP: 5/9/2014.

Code information: DESLORATADINE, Tablet, 5 mg has the following codes: Pedigree: AD30993_5, EXP: 2/28/2014.

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