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Recall Observatory FDA recall evidence

Drug product

DOCUSATE SODIUM, Capsule, 250 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00536375710.

D-936-2014

July 02, 2013

Class II

Product summary

Firm
Aidapak Services, LLC
Event
Event 65690
Status
Terminated
Classification
Class II
Quantity
16,044 Capsules
Official record key
drug-enforcement:D-936-2014

Official wording

Reason: Labeling: Label Mixup: DOCUSATE SODIUM, Capsule, 250 mg may have potentially been mislabeled as one of the following drugs: SACCHAROMYCES BOULARDII LYO, Capsule, 250 mg, NDC 00414200007, Pedigree: W003030, EXP: 6/12/2014; ISOSORBIDE MONONITRATE ER, Tablet, 30 mg, NDC 62175012837, Pedigree: AD21790_64, EXP: 5/1/2014; TRIHEXYPHENIDYL HCL, Tablet, 1 mg (1/2 of 2 mg), NDC 00591533501, Pedigree: AD7

Code information: DOCUSATE SODIUM, Capsule, 250 mg has the following codes: Pedigree: W003054, EXP: 6/12/2014; Pedigree: AD21846_11, EXP: 5/1/2014; Pedigree: W002512, EXP: 6/3/2014; Pedigree: AD76675_1, EXP: 6/3/2014; Pedigree: W002694, EXP: 6/5/2014; Pedigree: AD46257_16, EXP: 5/15/2014; Pedigree: AD60236_1, EXP: 5/22/2014; Pedigree: AD60578_5, EXP: 5/29/2014; Pedigree: AD73521_13, EXP: 5/30/2014; Pedigree: W003242, EXP: 6/17/2014; Pedigree: W003315, EXP: 6/18/2014.

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