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Recall Observatory FDA recall evidence

Drug product

DOXYCYCLINE HYCLATE Tablet, 100 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 53489012002

D-611-2014

July 02, 2013

Class II

Product summary

Firm
Aidapak Services, LLC
Event
Event 65707
Status
Terminated
Classification
Class II
Quantity
50 Tablets
Official record key
drug-enforcement:D-611-2014

Official wording

Reason: Labeling: Label Mixup; DOXYCYCLINE HYCLATE, Tablet, 100 mg may be potentially mislabeled as DESLORATADINE, Tablet, 5 mg, NDC 00085126401, Pedigree: AD30993_5, EXP: 2/28/2014.

Code information: DOXYCYCLINE HYCLATE Tablet, 100 mg has the following code Pedigree: AD30993_8, 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