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Recall Observatory FDA recall evidence

Drug product

diphenhydrAMINE HCl, Tablet, 25 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00904555159

D-483-2014

July 02, 2013

Class II

Product summary

Firm
Aidapak Services, LLC
Event
Event 65707
Status
Terminated
Classification
Class II
Quantity
901 Tablets
Official record key
drug-enforcement:D-483-2014

Official wording

Reason: Labeling: Label Mixup; diphenhydrAMINE HCl, Tablet, 25 mg may be potentially mislabeled as ATORVASTATIN CALCIUM, Tablet, 40 mg, NDC 00378212177, Pedigree: AD33897_10, EXP: 5/9/2014; ATORVASTATIN CALCIUM, Tablet, 10 mg, NDC 00378201577, Pedigree: W002774, EXP: 6/6/2014; PRENATAL MULTIVITAMIN/ MULTIMINERAL, Tablet, NDC 51991056601, Pedigree: W003511, EXP: 6/21/2014; VENLAFAXINE, Tablet, 25 mg

Code information: diphenhydrAMINE HCl, Tablet, 25 mg has the following codes Pedigree: AD33897_13, EXP: 5/9/2014; Pedigree: W002775, EXP: 6/6/2014; Pedigree: W003513, EXP: 6/21/2014; Pedigree: AD67992_4, EXP: 5/28/2014.

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