Skip to content
Recall Observatory FDA recall evidence

Drug product

DOCUSATE SODIUM, Capsule, 250 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00536375701.

D-935-2014

July 02, 2013

Class II

Product summary

Firm
Aidapak Services, LLC
Event
Event 65690
Status
Terminated
Classification
Class II
Quantity
1204 Capsules
Official record key
drug-enforcement:D-935-2014

Official wording

Reason: Labeling: Label Mixup: DOCUSATE SODIUM, Capsule, 250 mg may have potentially been mislabeled as one of the following drugs: PIOGLITAZONE, Tablet, 15 mg, NDC 00591320530, Pedigree: AD25452_10, EXP: 4/30/2014; PHOSPHORUS, Tablet, 250 mg, NDC 64980010401, Pedigree: AD54498_1, EXP: 5/20/2014; LACTOBACILLUS GG, Capsule, 0, NDC 49100036374, Pedigree: AD65457_16, EXP: 5/24/2014; guaiFENesin ER, Table

Code information: DOCUSATE SODIUM, Capsule, 250 mg has the following codes: Pedigree: AD25452_13, EXP: 5/3/2014; Pedigree: AD54498_4, EXP: 5/20/2014; Pedigree: AD65457_19, EXP: 5/24/2014; Pedigree: W003358, EXP: 6/19/2014; Pedigree: W003558, EXP: 6/24/2014; Pedigree: AD60211_11, EXP: 5/22/2014; Pedigree: W003114, EXP: 6/13/2014; Pedigree: AD37063_4, EXP: 5/13/2014; Pedigree: AD73652_1, EXP: 5/29/2014.

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