FDAClass IIJanuary 29, 2014

Docusate Sodium recall: Labeling Error

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

Why was Docusate Sodium recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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.

Product
DOCUSATE SODIUM, Capsule, 250 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00536375701.
Recalling firm
Aidapak Services, LLC
Quantity
1204 Capsules
Distribution
Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Recall date
January 29, 2014
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls