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Recall Observatory FDA recall evidence

Drug product

PROPRANOLOL HCL Tablet, 10 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 23155011010

D-531-2014

July 02, 2013

Class II

Product summary

Firm
Aidapak Services, LLC
Event
Event 65707
Status
Terminated
Classification
Class II
Quantity
1,999 Tablets
Official record key
drug-enforcement:D-531-2014

Official wording

Reason: Labeling: Label Mixup; PROPRANOLOL HCL Tablet, 10 mg may be potentially mislabeled as LACTOBACILLUS ACIDOPHILUS, Capsule, NDC 54629011101, Pedigree: AD65311_4, EXP: 5/24/2014.

Code information: PROPRANOLOL HCL Tablet, 10 mg has the following code Pedigree: AD65317_1, EXP: 5/24/2014.

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