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Recall Observatory FDA recall evidence

Drug product

CITALOPRAM Tablet, 10 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 57664050788

D-630-2014

July 02, 2013

Class II

Product summary

Firm
Aidapak Services, LLC
Event
Event 65707
Status
Terminated
Classification
Class II
Quantity
299 Tablets
Official record key
drug-enforcement:D-630-2014

Official wording

Reason: Labeling:Label Mixup; CITALOPRAM Tablet, 10 mg may be potentially mislabeled as OXYBUTYNIN CHLORIDE, Tablet, 5 mg, NDC 00603497521, Pedigree: AD52778_61, EXP: 5/20/2014; COENZYME Q-10, Capsule, 30 mg, NDC 00904501546, Pedigree: W002814, EXP: 6/7/2014.

Code information: CITALOPRAM, Tablet, 10 mg has the following codes Pedigree: AD56921_1, EXP: 5/21/2014; Pedigree: W002844, EXP: 6/7/2014.

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