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Recall Observatory FDA recall evidence

Drug product

PROPRANOLOL HCL ER, Capsule, 60 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00228277811.

D-885-2014

July 02, 2013

Class II

Product summary

Firm
Aidapak Services, LLC
Event
Event 65690
Status
Terminated
Classification
Class II
Quantity
100 Capsules
Official record key
drug-enforcement:D-885-2014

Official wording

Reason: Labeling: Label Mixup: PROPRANOLOL HCL ER, Capsule, 60 mg may have potentially been mislabeled as the following drug: CINACALCET HCL, Tablet, 30 mg, NDC 55513007330, Pedigree: AD52778_82, EXP: 5/21/2014.

Code information: PROPRANOLOL HCL ER, Capsule, 60 mg has the following codes: Pedigree: AD54605_4, EXP: 5/20/2014.

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