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Recall Observatory FDA recall evidence

Drug product

DESMOPRESSIN ACETATE, Tablet 0.1 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00591246401.

D-968-2014

July 02, 2013

Class II

Product summary

Firm
Aidapak Services, LLC
Event
Event 65690
Status
Terminated
Classification
Class II
Quantity
98 Tablets
Official record key
drug-enforcement:D-968-2014

Official wording

Reason: Labeling: Label Mixup: DESMOPRESSIN ACETATE, Tablet 0.1 mg may have potentially been mislabeled as the following drug: LOXAPINE, Capsule, 5 mg, NDC 00591036901, Pedigree: AD46426_7, EXP: 5/15/2014.

Code information: DESMOPRESSIN ACETATE, Tablet 0.1 mg has the following codes: Pedigree: AD46426_16, EXP: 5/15/2014.

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