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Recall Observatory FDA recall evidence

Drug product

PROPRANOLOL HCL Tablet, 10 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 23155011001

D-529-2014

July 02, 2013

Class II

Product summary

Firm
Aidapak Services, LLC
Event
Event 65707
Status
Terminated
Classification
Class II
Quantity
2,299 Tablets
Official record key
drug-enforcement:D-529-2014

Official wording

Reason: Labeling: Label Mixup; PROPRANOLOL HCL, Tablet, 10 mg may be potentially mislabeled as PERPHENAZINE, Tablet, 16 mg, NDC 00781104901, Pedigree: AD21790_31, EXP: 5/1/2014; buPROPion HCl ER (XL), Tablet, 150 mg, NDC 67767014130, Pedigree: AD52412_4, EXP: 4/30/2014; MULTIVITAMIN/MULTIMINERAL LOW IRON, Tablet, NDC 64376081601, Pedigree: AD60272_31, EXP: 5/22/2014; PERPHENAZINE, Tablet, 16 mg, NDC

Code information: PROPRANOLOL HCL Tablet, 10 mg has the following codes Pedigree: AD21790_34, EXP: 5/1/2014; Pedigree: AD52390_1, EXP: 5/17/2014; Pedigree: AD60272_37, EXP: 5/22/2014; Pedigree: W002732, EXP: 6/6/2014; Pedigree: W003229, EXP: 6/17/2014; Pedigree: AD60272_34, EXP: 5/22/2014; Pedigree: W003684, EXP: 6/25/2014; Pedigree: W002618, EXP: 6/4/2014; Pedigree: W003002, EXP: 6/11/2014; Pedigree: W003068, EXP: 6/12/2014; Pedigree: W003545, EXP: 6/21/2014.

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